U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Depuy synthes is initiating a recall of certain lots of the craniomaxillofacial distraction system (ab distractor bodies and bc distractor bodies) because they may reverse post-operatively.
Action
The firm, DePuy Synthes, sent "Urgent Notice: Medical Device Recall" letters dated April 16, 2014 to affected customers. The letter identified the affected product, reason for recall, potential patient impact, mitigation steps for patients with distractors currently implanted and actions to be taken. Customers were instructed to review inventory, immediately remove the affected lots from stock, complete verification section of the letter and return the affected product.
For questions call 610-719-5450 or contact your DePuy Synthes Sales consultant.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Warmer, infant radiant - Product Code FMT
Cause
Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative oxygen saturation and pulse rate alarm notifications to the caregiver.
Action
GE Healthcare notified Biomedical/Clinical Engineering managers, Labor & Delivery/ NICU Nurse managers, Respiratory Therapy Managers and Directors of Risk Management by letter 04/02/2014. End users were advised that they may continue to use the system provided they follow the GE recommended actions:
1) If in use with a patient, turn off the Nellcor SpO2 function in the control panel and switch to an approved alternate form of SpO2 measurement.
2) Prior to using the affected GE warmer with the Nellcor SpO2 function, or resuming the use of this function with any patient, contact your hospital Bio-Med or qualified technician to check the Nellcor SpO2 alarm functionality using either an adult Nellcor SpO2 sensor or a Nellcor SpO2 simulator following the applicable instructions in the Appendix
3) If the test activates a Low Pulse Rate alarm, the user-adjusted Nellcor SpO2 alarm limits are functioning properly and the warmer can be placed back in clinical service.
End users were also advised that alarm functionality must be re-checked following every service event requiring access to the internal electronics and during annual preventative maintenance, until revised software is installed.
4) If the test does NOT activate a Low Pulse Rate alarm, remove the warmer from clinical service and contact your local GE Healthcare Service Representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Warmer, infant radiant - Product Code FMT
Cause
Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative oxygen saturation and pulse rate alarm notifications to the caregiver.
Action
GE Healthcare notified Biomedical/Clinical Engineering managers, Labor & Delivery/ NICU Nurse managers, Respiratory Therapy Managers and Directors of Risk Management by letter 04/02/2014. End users were advised that they may continue to use the system provided they follow the GE recommended actions:
1) If in use with a patient, turn off the Nellcor SpO2 function in the control panel and switch to an approved alternate form of SpO2 measurement.
2) Prior to using the affected GE warmer with the Nellcor SpO2 function, or resuming the use of this function with any patient, contact your hospital Bio-Med or qualified technician to check the Nellcor SpO2 alarm functionality using either an adult Nellcor SpO2 sensor or a Nellcor SpO2 simulator following the applicable instructions in the Appendix
3) If the test activates a Low Pulse Rate alarm, the user-adjusted Nellcor SpO2 alarm limits are functioning properly and the warmer can be placed back in clinical service.
End users were also advised that alarm functionality must be re-checked following every service event requiring access to the internal electronics and during annual preventative maintenance, until revised software is installed.
4) If the test does NOT activate a Low Pulse Rate alarm, remove the warmer from clinical service and contact your local GE Healthcare Service Representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Labeling changes have been made related to mr (magnetic resonance imaging) conditions as a result of changes in required protocols to designate a product mr safe, mr conditional, or mr unsafe.
Action
Synthes sent an Urgent Notice dated April 10, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:
All Synthes External Fixation devices should be treated as MR Conditional.
" Synthes asks that you review the information contained in this Labeling Notification and complete the Verification Section located on Page 3.
" Discard outdated revisions of the Technique Guides noted in the table below.
" Update your records with updated Labeling Infonnation.
" Forward this Medical Device Labeling Update to anyone in your facility that needs to be infonned, especially those personnel that conduct MR testing.
" If the Verification Fonn is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual in pg. 3.
" Updated product literature can be located on the Synthes website at
http://www.syntheskyo.com/trauma kyo/home/home.htm.
" Please see the attached inseii for current conditions for use in the MR environment.
" Maintain a copy of this notice.
Customers with questions were instructed to call 610-719-5450.
For questions regarding this recall call 610-719-5000.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Warmer, infant radiant - Product Code FMT
Cause
Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative oxygen saturation and pulse rate alarm notifications to the caregiver.
Action
GE Healthcare notified Biomedical/Clinical Engineering managers, Labor & Delivery/ NICU Nurse managers, Respiratory Therapy Managers and Directors of Risk Management by letter 04/02/2014. End users were advised that they may continue to use the system provided they follow the GE recommended actions:
1) If in use with a patient, turn off the Nellcor SpO2 function in the control panel and switch to an approved alternate form of SpO2 measurement.
2) Prior to using the affected GE warmer with the Nellcor SpO2 function, or resuming the use of this function with any patient, contact your hospital Bio-Med or qualified technician to check the Nellcor SpO2 alarm functionality using either an adult Nellcor SpO2 sensor or a Nellcor SpO2 simulator following the applicable instructions in the Appendix
3) If the test activates a Low Pulse Rate alarm, the user-adjusted Nellcor SpO2 alarm limits are functioning properly and the warmer can be placed back in clinical service.
End users were also advised that alarm functionality must be re-checked following every service event requiring access to the internal electronics and during annual preventative maintenance, until revised software is installed.
4) If the test does NOT activate a Low Pulse Rate alarm, remove the warmer from clinical service and contact your local GE Healthcare Service Representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Introducer, catheter - Product Code DYB
Cause
Arrow is recalling the arrow¿ percutaneous sheath introducer kits due to dilator tip damage noted during internal inspection. dilator tip damage has the potential to result in vessel
damage.
Action
Teleflex/Arrow International sent an Urgent Medical Device Recall Notification letter dated April 17, 2014, to distributors and end users. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine any affected product and to complete the enclosed Recall Acknowledgement Form and fax it to 1-800-343-2935 to return product. Customers would be contacted by a customer service representative for a Return Goods Authorization (RGA) Numbers and would be provided instructions for the return of the product. Customers should complete the form whether they have affected product or not. Customers with questions were instructed to call 1-800-343-2935.
For questions regarding this recall call 610-378-0131.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The sterile barrier in the packaging may be compromised due to cracks in the thermoform tray that may occur during transport of the product in extreme cold weather conditions, in conjunction with mechanical impact.
Action
Tenex Health sent an Urgent Medical Device Recall notification letter dated April 15, 2014, to all consigness. The letter informed consignees of the recall, manufacturer, product name, product code, reason for recall, recall carried out to the user level, instructions to customers, contact information, label examples, and response form was provided. Consignees were instructed to immediately examine their inventory per the enclosed instructions, if they identify any of the affected product within their inventory, they should segregate the product and immediately return only MicroTips with damaged trays to the address below, using the Tenex Health, Inc. FEDEX account number and referencing the Returned Goods Authorization (RGA) number.
RGA#
Tenex Health, Inc.
26902 Vista Terrace
Lake Forest, CA 92630
Customers were asked to complete and return the enclosed response form as soon as possible.
Customers with questions should contact Tenex at (949) 454-7500, ext. 209
or email tanaka@tenexhealth.com.
For questions regarding this recall call (949) 454-7500.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Cause
A small number of vista air compressors were miswired, which if installed and powered up, could cause a fire, or become an electrical shock hazard.
Action
Siemens sent an Urgent Medical Device Correction letter dated April 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers.
Actions to be Taken by the Customer
1. If an Air Compressor has already been delivered to your laboratory, or is
delivered in the future for installation by your Siemens Healthcare Customer
Service Engineer, please do not make any attempt to install the Air Compressor
by yourself.
2. Please notify your local Siemens Healthcare Diagnostics Customer Care Center when an Air Compressor is at your site so arrangements may be made for installation by a Siemens Healthcare Diagnostics Customer Service Engineer.
Please discuss the content of this letter with your Medical Director.
Please complete and return the Field Correction Effectiveness Check Form attached to this letter.
Please retain this letter with your laboratory records and forward this letter to those who may have received this product.
We apologize for the inconvenience this situation has caused. If you have any
questions, please contact Siemens Customer Care Center - Technical Solutions at (800-441-9250) or your local Siemens technical support representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Immunohistochemistry reagents and kits - Product Code NJT
Cause
Bond ready to use primary antibody thyroglobulin does not function as intended up to the expiry date on the product labelling. this was detected through an on-going stability program. there is a link between the age of the product and staining intensity.
Action
Leica Biosystems sent a Medical Device Recall Notification letter dated April 18, 2014, to all affected customers. The letter included instructions for customers to: 1) assess any results previously obtained by using the recalled products; 2) identify and destroy any unused or partly used recalled products or confirm that the recalled products are no longer in stock; and, 3) complete and return the attached Medical Device Recall Notification Acknowledgement Form. Customers with questions were instructed to contact Leica Microsystems by e-mail at LMGRA@leica-microsystems.com.
For questions regarding this recall call 847-405-5413.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Hearing aid, bone conduction - Product Code LXB
Cause
Cochlear america is recalling cochlear baha soft tissue gauge due to possible manufacturing imperfection in the smooth surface of the metal that could potentially leave residual metal on the patient's skin.
Action
Customers were notified via letter on 4/17/14. This communication included an explanation of the recall and instructions to quarantine and return products.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Couch, radiation therapy, powered - Product Code JAI
Cause
If screws are not properly tightened with a torque wrench they may become loose over time.
Action
Corrective Action #1 - Important Field Safety Notice 618 01 302 002 was issued April 2014. The Notice informs end users about the problem and the potential clinical impact. It also give a recommendation how the risk can be mitigated - inspect the screws and if loose contact Elekta Service to tighten the screws with 20 Nm. The notice also advises the customer that a modification kit will be released that introduces an improved screw solution. The solution will be implemented on all affected products when available. Corrective Action #2 Permanent Solution - Replace Current Screws - An improved screw has been designed and will be available for Elekta Field Service organization to replace on all affected products at the end of April. The new design solution provides a very long used thread depth, exceeding the standard recommended thread-depths by far. This design will prevent the screws from loosening.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Shunt, central nervous system and components - Product Code JXG
Cause
Aic (usa) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter.
Action
Aesculap sent an Important Correction & Removal recall letter dated April 21, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
An Aesculap Sales Representative will contact you to schedule return of any affected inventory and replace your product. Please complete the attached Inventory Sheet which is necessary to comply with FDA regulations. When completing the inventory sheet, please be sure to fill in the quantity
being returned. If you cannot locate the product, please provide an explanation as to why the inventory will not be returned (discarded, etc.).
AIC (USA) appreciates your cooperation on this matter and apologizes for the inconvenience this may cause. Thank you for your patience and continued support of this product. Please contact (610) 984-9414 with any questions.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
It has been identified that in a reject image workflow where multiple studies are simultaneously opened on the centricity pacs ra1000 workstation and images are rejected from the active displayed study, images for the previously displayed study may also be rejected. the issue can occur with a previously displayed study that remains open in the background.
if one or more, but not all, images in.
Action
An URGENT MEDICAL DEVICE CORRECTION letter dated April 3, 2014 was sent to all direct accounts. The letter included instruction to customers to use until the permanent fix for this issue is deployed: 1) Check to see if the DelRejImg task is active and running. a) Log into CA Tool. b) From the Navigation menu, select System Monitor. c) From the pull down menu, select Dbase Maintenance. d) Scroll to the DelRejImg task (this list is alphabetical). e) Review the Task Status. Possible statuses are IDLE or SUSPEND f) If the task status is set to SUSPEND The task is not running. g) If the task is set to IDLE, move to Step 2. 2) Check the Minimum Rejected Image Deletion Time. a) From the Navigation menu, select Sys. Configuration. b) From the pull down menu, select PACS Configuration. c) Scroll to Minimum Rejected Image Deletion Time (this list is alphabetical). d) Review the Value field. e) If the value field is a negative integer (such as the default setting of -1), the Delete Rejected Image process is NOT running and there is no patient safety hazard. If the value field is a positive integer (such as 1 or higher), the Delete Rejected Image process IS running and there is a potential patient safety hazard. 3) A GE Healthcare Service Representative will remove the DelRejImg task from the task table in the Centricity PACS database. This will prevent the DelRejImg task from running, and prevent any rejected images from being deleted. This feature is being removed entirely from the 3.2 release family of Centricity PACS and will be reinstated in a future 4.X workstation release of Centricity PACS. 4) Perform the reject image workflow with only one patient study open at a time.
A future release of Centricity PACS will address the unintentional rejected image issue.
Until a correction for the unintentional rejected image issue is available, a GE Healthcare service representative will remove the DelRejImg task table in the Centricity PACS database. This will remove the re
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
On April 24, 2014, consignees were notified of the recall via letter. They were instructed to do the following: Inspect inventory and segregate any unused Blankets listed in the notification, complete and return the attached Confirmation Form by fax or e-mail within 7 days of receipt of this notice, and destroy the product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
contact lens solution - Product Code LYL
Cause
Out of specification results for one of the two disinfectants.
Action
Consignees were notified via registered mail starting 04/21/2014.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Ventilator, continuous, facility use - Product Code CBK
Cause
Reports of the audible alarm not sounding when the ventilator is in an alarm state. the ventilator, as well as the visual and remote alarms, continue to operate normally.
Action
Newport Medical Instruments, Inc. (Newport), a wholly-owned subsidiary of Covidien is conducting a voluntary field corrective action via letters to be sent during the week of April 28, 2014.
The letter titled "URGENT MEDICAL DEVICE FIELD SAFETY CORRECTIVE ACTION" informed customers of the recall by providing: reason for recall, product description, information on affected serial numbers regardless of software versions, issue identified, recommended actions to help mitigate risk to the patient, actions to eliminate the occurrence of this issue, important safety reminders, and contact information. Customers are to contact Technical Support Department to receive a software update kit, and then follow the instructions provided once the kit has been received. The attached verification and completion form should be completed and faxed.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
A complaint reported that the archiving method at one customer site was changed from implicit to explicit, and the cleanup procedure enabled by the explicit archiving method may have deleted data from archive itself.
Action
Siemens sent a Customer Safety Advisory Notice dated April 3, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Our service organization already checked all syngo Imaging sites and did not find any other occurrence of the wrongly configured link.
Additionally our service organization will include the check for such wrongly configured links into the existing proactive site monitoring procedures.
We appreciate your understanding and cooperation with this safety advisory and ask you to immediately instruct your personnel accordingly. Please include this safety advisory notice in your operator's manual. In the interests of safety, we ask that you perform the above preventive measures and inform all affected personnel immediately.
If you have sold this device/equipment and it is no longer in your possession, we kindly ask that you forward this safety notice to the new owner of this device/equipment. Please inform us about the new owner of the device/equipment.
We regret any inconvenience that this may cause, and we thank you in advance for your understanding. For further questions please call (610) 219-6300.
.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Interventional fluoroscopic x-ray system - Product Code OWB
Cause
It was determined that under rare environmental conditions (i.E., extremely dry air in combination with a highly isolated floor) electrostatic discharges (esd) >8 kv may trigger an unintended movement of the axiom luminos drfsystem which may lead to an emergency situation and pose danger to the patients, operating personnel or to the unit.
Action
Siemens sent an Safety Advisory Notice dated April 11, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
What steps can the user take to avoid the potential risk of this issue?
Press one of the red emergency STOP buttons immediately in case of an unintended movement. The system needs to be restarted afterwards to be fully functional again.
How will the issue finally be resolved?
Siemens is preparing a modification of the Luminos dRF system control console that will resolve this potential malfunction. The field modification will be available by end of May 2014.
We appreciate your understanding and cooperation with this safety advisory notice and ask you to immediately instruct your personnel accordingly. Please ensure that this safety advisory notice is placed in the system's instructions for use until the update has been installed.
If you have sold this device/equipment and it is no longer in your possession, we kindly ask that you forward this safety notice to the new owner of this device/equipment. Please inform us about the new owner of the device/equipment.
For further questions please call (610) 219-6300.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Instrument, cutting orthopedic - Product Code HTZ
Cause
It was discovered internally that the face of the synthes matrix mandible short cut plate cutter has the potential for discoloration/corroded material in the affected lot.
Action
Synthes Inc. sent an Urgent Medical Device Recall Notice dated April 22, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
If you DO have any of the identified devices, please take the following steps:
Contact DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number . Complete the Verification Section at the end of this letter by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found. Please include your name, title, telephone number and signature in the spaces provided.
Return the Verification Section (page 3 of this letter) with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132.
Return a copy of the Verification Section (page 3 of this letter) to DePuy Synthes by: Fax: 866-324-3731 or Scan/email: Synthes7726@stericycle.com
If you DO NOT have the identified product, please take the following steps:
Complete the attached Verification Section at the end of this letter by checking the appropriate box indication that no affecteded product has been located. Please include your name, title, telephone number and signature in the spaces provided this return documentation acknowledges your receipt of medical device removal information.
Return the Verification Section (page 3 of this letter) to DePuy Synthes by:
Fax: 866-324-3731 or Scan/email: Synthes7726@stericycle.com
Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual on page 3 of the notification.
If you have any questions, please call 610-719-5450 or contact your DePuy Synthes sales consultant.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Subsystem, water purification - Product Code FIP
Cause
Mar cor purification manufactured central water plant (cwp) reverse osmosis system, models 102, 104 and 106. this correction has been initiated due to a potential situation with a specific lot of the water inlet solenoid valve. the potential exists that the water inlet solenoid valve could cease to function. if this occurs, cwp will stop producing reverse osmosis water.
Action
Consignees were sent on 4/24/2014 a Mar Cor Purification "Urgent Medical Device Correction" letter. The letter described the problem and the product involved in the recall. Advised consignees to examine their CWP unit to determine if it is subject to this correction. If your unit is involved in the recall inform all staff of the potential issue. Contact Scott Nicholas, Project Coordinator / Service Trainer at 1-800-633-3038 to schedule replacement of the water inlet solenoid valve. This correction is to be carried to the user level. Consignees were requested to complete and return the "CWP Correction Notice Response Form". For questions they should contact Scott Nichols, Project Coordinator / Service Trainer at 1-800-633-3080.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Laparoscope, general & plastic surgery - Product Code GCJ
Cause
Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.
Action
Davol, Inc., Subs. C. R. Bard, Inc.sent an Urgent Medical Device Recall letter dated April 28, 2014, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to examine their inventory and quarantine product subject to the recall, contact Davol Customer Service at 1-800-556-6275 or C.R. Bard's Medical Services and Support Department at 1-800-562-0027 for instructions on how to return the product to Davol, Consignees were also instructed to complete and return the recall effectiveness check form, and notify their customers if the product was further distributed.
For questions regarding this recall call 1-800-556-6275.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
ceiling mounted surgical light system - Product Code FSY
Cause
Potential for the welded seam in affected monitor spring arms to crack and/or break.
Action
On April 11, 2014 the firm sent Urgent Voluntary Field Correction Notices to their customers.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Laparoscope, general & plastic surgery - Product Code GCJ
Cause
Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.
Action
Davol, Inc., Subs. C. R. Bard, Inc.sent an Urgent Medical Device Recall letter dated April 28, 2014, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to examine their inventory and quarantine product subject to the recall, contact Davol Customer Service at 1-800-556-6275 or C.R. Bard's Medical Services and Support Department at 1-800-562-0027 for instructions on how to return the product to Davol, Consignees were also instructed to complete and return the recall effectiveness check form, and notify their customers if the product was further distributed.
For questions regarding this recall call 1-800-556-6275.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Laparoscope, general & plastic surgery - Product Code GCJ
Cause
Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.
Action
Davol, Inc., Subs. C. R. Bard, Inc.sent an Urgent Medical Device Recall letter dated April 28, 2014, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to examine their inventory and quarantine product subject to the recall, contact Davol Customer Service at 1-800-556-6275 or C.R. Bard's Medical Services and Support Department at 1-800-562-0027 for instructions on how to return the product to Davol, Consignees were also instructed to complete and return the recall effectiveness check form, and notify their customers if the product was further distributed.
For questions regarding this recall call 1-800-556-6275.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
System, nuclear magnetic resonance imaging - Product Code LNH
Cause
Ge healthcare has recently become aware of a potential safety issue with certain ge mri products. patient egress from the system can be delayed or impeded if the cradle release handle and/or cradle release block mechanism malfunctions or becomes misaligned. this could make the safe removal of the patient from the system difficult.
Action
Consignees were sent on 4/23/2014 a GE Healthcare Ref # 60863 "Urgent Medical Device Correction" letter dated April 18, 2014. The letter was addressed to Hospital Administrators / Risk Mangers, Radiology Department Mangers and Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and Contact Information. If customers encounter the stated problem with the device, they should contact their GE Healthcare Service Representative for an inspection and necessary repairs. GE will correct all affected devices at no cost to the customers. For questions customers should contact their local service representative.