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
Stretcher, Wheeled - Product Code FPO
Cause
The firm has determined that the brake rod assemblies of various stretchers that were built with a 5th wheel were manufactured with roll pins that did not meet the materials specifications. some roll pins may have fractured during the assembly process and could fall out of the brake rod assemblies, rendering the brake or steer systems inoperable from certain pedals or causing a reduction in overa.
Action
Stryker Medical sent an "Urgent Medical Device Correction" dated July 19 ,2011 to all affected customers.
The letter included; the name and model numbers of the stretchers, the reason for the correction and dates of manufacture. It contained the instructions to check the braking system and if found to be inoperable, to remove it from service, and if operable to check prior to each use. Also, information regarding contacting the recipients of any loaned or sold stretchers to relay the information in the letter and Medwatch reporting information. A self addressed postcard to confirm receipt of the letter was also included.
For additional information call (269) 389-6604.
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
centrifuge - Product Code JQC
Cause
Potential for bucket and insert not seated on the rotor to cause the lid to break and buckets to be ejected.
Action
Global Focus Marketing and Distribution, Ltd issued a press release on 07/19/11 and a URGENT: DEVICE RECALL letter was mailed to the firm's customers on 07/15/11 and 07/21/11. Discontinue use. For questions, contact: (800) 323-4306 or silencer@gfmd.com
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 correction -- the locking cap was not able to be loosened, resulting in the breakage of the screwdriver or the rod to be cut and the assembly to be removed (screw, cap, and rod). this poses a potential risk of significant prolongation of or time.
Action
The firm initiated this action on March 11, 2011 by issuing an Urgent: Medical Device Labeling Correction letter to all consignees. The letter identified the affected product and stated the reason for the correction. It also instructed the consignee to review and attach the supplementary technique page to any MATRIX Spine System Technique Guides that they may have had in their facility. Customers are to complete the Verification Section of the letter and return it to the firm via mail, fax, or e-mail. If customers have questions, they can call 610-719-5063 or their Synthes Spine 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
Surgical Mesh - Product Code FTM
Cause
Surgical mesh for implantation may have elevated endotoxin levels.
Action
ACELL, Inc. sent an "Urgent: Medical Device Safety Alert" letter dated July 07, 2011 to all affected customers.
The letter notified customers (physicians) of the possibility of elevated endotoxin levels in the product and affected lots. They were instructed to monitor their patients receiving the affected implants.
For additional information please contact the Director of Regulatory Affairs & Quality Assurance at (410) 953-8508.
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, x-ray, angiographic - Product Code IZI
Cause
System freezes from 20 seconds up to one minute. no fluoroscopy exposure and no geometry movements during this time period.
Action
Philips Health Care North America sent a FIELD SAFETY CORRECTION ACTION letter dated July 4, 2011, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer.
This FCD will be identified as FCD72200200 and will be free of charge. This FCD consists a CD with the correct firmware and a installation procedure to implement the FCD correctly.
Please contact your local Philips representative. For further follow up please call (978 ) 687-1501.
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
Display, cathode-ray tube, medical - Product Code DXJ
Cause
Under certain circumstances, edits to an order can result in unintended scheduled interventions on the intellivue clinical information portfolio. a patient may receive interventions or additional medication doses that are not intended.
Action
Philips Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated July 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.
Customers are asked to follow the guidelines in the "Action to be taken by Customer/User" section of the Urgent Medical Device Correction Notice. Philips has developed a software upgrade to address this problem in the short term. This upgrade will be available immediately. This software upgrade will be performed by Philips service personnel. While customers await the correction of their devices, customers are instructed to follow the instructions for use for the device, which includes the directions to:
1. Always use the medication administration record (MAR) in determining patient care.
2. Always review orders and pending administrations in the administration record after any changes to an order are stored.
For the longer term, Philips is developing safeguards intended to minimize the potential for similar errors resulting from order changes and upgrade to be available in September 2011.
If you need any further information or support concerning this issue, please contact your local Philips 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.
Cardiac science corporation (csc) intent to end service support and discontinue accessory sales of powerheart g2 automated external defibrillators. customers are recommended to choose a replacement aed prior to the current aed displaying any "service required" self test messages.
Action
Cardiac Science Corporation (CSC) sent two "9200 SERIES CARDIAC SCIENCE AED NOTICE" letters dated August 2010 and March 2011 to all affected customers. The letters identifies the product, problem, and actions to be taken by the customers.
Customers are encouraged to upgrade their devices through special offers by calling CSC at 800-426-0337, Option 2.
For questions about the end of factory support for the affected devices, call the Technical Support team at 800-426-0337, Option 1.
*****In August 2011, Cardiac Science sent out another updated recall notification letter to their consignees. This letter stated that once a device has entered the "Service Required" state, please contact the firm at 800.426.0337 Option 2. Per prior notifications, the 9200 series AEDs have reached the end of service life and can no longer be repaired. Information about these notifications may be found as an announcement in the Services and Support section of Cardiac Science website.
Cardiac Science advised the customers to upgrade to a Powerheart AED G3 (this device supports the 2010 AHA/ERC Guidelines). It is strongly
recommended that customer to choose a replacement AED prior to the current AED displaying any "Service Required" self test messages. For information about special offers to help you upgrade please call 800.426.0337. Option 2.
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.
Cardiac science corporation (csc) has identified two errors, 0x48 and 0x99, that have repeatedly occurred during a device self-test in the g3 installed base over the last 6 years. these self test errors cause the device to enter into a service required state.
csc remind owners/operators of the powerheart aed devices to verify the "rescue readiness" of their equipment and follow maintenance pro.
Action
Cardiac Science began mailing out the recall notification letter on August 1, 2011, to all their US consignees via USPS first class mail.
Cardiac Science's distribution partners will receive a notification letter and be provided with a template letter to send to their customers directly.
CSC remind owners/operators of the Powerheart AED devices to check the status of of the AED every day to ensure it is Rescue Ready, and perform the regularly schedule maintenance as outlined in the Powerheart AED "Operator and Service Manual" provided with every AED.
Customers can call Cardiac Science at 800-426-0337 or e-mail at aed205@cardiacscience.com.
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
Mechanical Wheelchair - Product Code IOR
Cause
The pivot stud bolt comprising part of the backrest assembly of tilite zr series 2 and zra series 2 mechanical wheelchairs have shown a tendency to fail due to the head of the bolt being sheared off.
Action
An Urgent Medical Device Correction letter, Product Correction Kit , and the Installation Instructions were sent to domestic suppliers, international suppliers, Veterans Administration hospitals and international distributors by US Priority Mail and by FedEx three days service.
The letter identified the affected product and the reason for the recall. Customers were instructed not to send the product to their end user until the correction was made or to identify their end user and notify the end user of the product correction. Replacement parts and instructions to correct the issue were enclosed with the letter. Customers were to destroy the removed parts once they had completed the correction. Customers were to also return the Medical Device Correct Report that was provided, by fax to 509-586-2413, or email to ProdCorrection@tilite.com.
Customers can call Technical Support at 800-545-2266, ext. 239 with any questions about recall.
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.
Pressure lines maybe occluded and display incorrect tidal volumes.
Action
Respironics Novametrix, LLC on July 29, 2011 notified accounts via e-mail or tracked receipt, an Urgent - Medical Device Recall letter to notify customers of the issue and to instruct them on conditions for continued use. Monitors will need to be returned for functional performance testing at their facility. Customers can contact Respironics US Customer Service at 1-877-387-3311 for customers residing in the USA or +011 (203)697-6348 for International customers, if they have any questions or need additional information.
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.
Pressure lines maybe occluded and display incorrect tidal volumes.
Action
Respironics Novametrix, LLC on July 29, 2011 notified accounts via e-mail or tracked receipt, an Urgent - Medical Device Recall letter to notify customers of the issue and to instruct them on conditions for continued use. Monitors will need to be returned for functional performance testing at their facility. Customers can contact Respironics US Customer Service at 1-877-387-3311 for customers residing in the USA or +011 (203)697-6348 for International customers, if they have any questions or need additional information.
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.
Potential failure of the retention component of the master tool manipulator (mtm) of the intuitive surgical da vinci si surgical system which could cause uncontrolled movement.
Action
Intuitive Surgical sent an "URGENT- MEDICAL DEVICE CORRECTION" letter dated July 1, 2011 to all affected customers. Customers were asked to complete the attached response form and return as per the instructions. The letter identifies the product, problem, and actions to be taken by the customers. The letter reinforce to customers to follow the product labeling WARNING. The letter states that all affected customers sites will be receiving a call from a Customer Support staff to schedule a retrofit of the component. A letter was also sent to non affected customers to inform them of the urgent medical device correction and actions to be taken.
If you have any questions, please contact Customer Service at 1-800-876-1310 or for Outside United States call +41 21 821 2020.
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
implantable infusion pump - Product Code LKK
Cause
Medtronic is updating information regarding the potential for reduced battery performance that can lead to sudden loss of therapy in a small percentage of medtronic model 8647 synchromed ii pumps that was communicated with healthcare providers in july 2009. the purpose of the current communication is to provide updated information regarding the scope and occurrence of this issue and to emphasize.
Action
Medtronic Neuromodulation notified physicians with an Urgent Medical Device Correction letter beginning July 05, 2011. A press was issued July 08, 2011. The letter described the issue, severity, recommendations if they notice issue, and patient management recommendations.
UPDATE: in November 2011, MDT began to exchange unused pumps in inventory with pumps that contained the new battery. A letter dated November 2011 was left behind at locations in which the MDT representative swapped out the devices.
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 become aware of two potential safety issues associated with mr products (optima mr450w, discovery mr450, discovery mr750, brivo mr355, optima mr360) that may impact patient safety.
1) inline post-processed (i.E. automated post-processing) image locations are not correctly annotated under some conditions.
2) reference images displayed in functool fibertrak do not match with.
Action
GE Healthcare sent an "Urgent Medical Device Correction" letter dated July 27, 2011 to customers with affected systems. The letter described the recalled product, safety issues and recommended actions to be taken. The letter provided immediate mitigation (Safety Instuctions) that address each issue. The letter states that the recalling firm will contact customers to arrange to provide a software upgrade to all affected systems at no cost. For any questions concerning this notification contact your local 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
System, nuclear magnetic resonance imaging - Product Code LNH
Cause
Ge healthcare has become aware of two potential safety issues associated with mr products (optima mr450w, discovery mr450, discovery mr750, brivo mr355, optima mr360) that may impact patient safety.
1) inline post-processed (i.E. automated post-processing) image locations are not correctly annotated under some conditions.
2) reference images displayed in functool fibertrak do not match with.
Action
GE Healthcare sent an "Urgent Medical Device Correction" letter dated July 27, 2011 to customers with affected systems. The letter described the recalled product, safety issues and recommended actions to be taken. The letter provided immediate mitigation (Safety Instuctions) that address each issue. The letter states that the recalling firm will contact customers to arrange to provide a software upgrade to all affected systems at no cost. For any questions concerning this notification contact your local 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.
Shaft tip (casting) does not meet the sne 416
specification, which could result in rusting of the tendon strippers.
Action
Smith & Nephew sent an Urgent - Product Recall Notification letter dated July 7, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete the form included in the letter and return to Hoangthi.le@smith-nephew.com or fax to 508-261-3620. Each affiliate must then notify each facility affected by the recall. To return product and obtain credit or order replacement product customers should contact the Smith & Nephew Endoscopy Returns at 800-343-5717 (option 3) for a Return Authorization (RA) or send an email to, endo.andreturns@smith-nephew.com.
For questions, contact Hoangthi by phone at 508-337-3731.
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
Electrode, ion specific, potassium - Product Code CEM
Cause
K+ results on the gem premier 4000 are too low when compared to a reference analyzer, with
biases exceeding allowable error claim of a¿ 0.5 moul.
Action
The firm, Instrumentation Labs, issued a Revised "Urgent Field Safety Notification" letter dated July 14, 2011, to GEM Premier 4000 customers. The letter describes the product, problem, updated issue description and actions to be taken. The customers were instructed to follow the instructions to Disable K+ Parameter ,provided in the letter, to eliminate the potential of erroneous K+ result reporting and to complete and return the MANDATORY RESPONSE TRACKING FORM immediately via fax at 781-861-4207 or email to ra-usa@ilwww.com.
The letter also noted an Important Change to Customer Actions from June Urgent Field Safety Notification.
Prior strategy :
Instrumentation Laboratories (IL) notified U.S and Canadian customers via the Urgent Field Safety Notification mailed USPS between June 2 - 3,2011. International Affiliates / Dealers notified through e-mail on June 1, 2010. A response (tracking) form was included. A Worldwide Regulatory Notice was e-mailed on May 31.2011.to IL country affiliates and distributors, notifying them of the issue, providing a risk summary and the support documentation for the notification. The customer notification will be handled per their local regulatory requirements.
If you have questions regarding this notification, please contact IL at 800-678-0710, press 2 at prompt.
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
Electrode, ion specific, potassium - Product Code CEM
Cause
K+ results on the gem premier 4000 are too low when compared to a reference analyzer, with
biases exceeding allowable error claim of a¿ 0.5 moul.
Action
The firm, Instrumentation Labs, issued a Revised "Urgent Field Safety Notification" letter dated July 14, 2011, to GEM Premier 4000 customers. The letter describes the product, problem, updated issue description and actions to be taken. The customers were instructed to follow the instructions to Disable K+ Parameter ,provided in the letter, to eliminate the potential of erroneous K+ result reporting and to complete and return the MANDATORY RESPONSE TRACKING FORM immediately via fax at 781-861-4207 or email to ra-usa@ilwww.com.
The letter also noted an Important Change to Customer Actions from June Urgent Field Safety Notification.
Prior strategy :
Instrumentation Laboratories (IL) notified U.S and Canadian customers via the Urgent Field Safety Notification mailed USPS between June 2 - 3,2011. International Affiliates / Dealers notified through e-mail on June 1, 2010. A response (tracking) form was included. A Worldwide Regulatory Notice was e-mailed on May 31.2011.to IL country affiliates and distributors, notifying them of the issue, providing a risk summary and the support documentation for the notification. The customer notification will be handled per their local regulatory requirements.
If you have questions regarding this notification, please contact IL at 800-678-0710, press 2 at prompt.
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.
Biosense webster has initiated a voluntary field notification to all customers that have a stockert 70 radio frequency generator, to communicate undetected software anomalies in the form of software release note in order to amend the labeling and thereby enhance the safety of the product.
Action
The recall communication was initiated on 7/8/11 and 7/11/11 with Biosense Webster forwarding A Customer Notification Letter, Acknowledgement Form and Software Release Note (Attachments 3, 4 and 1) via FedEx to all U.S. customers who purchased the Stockert 70 Radio Frequency Generator.
Two letters and forms were sent to U.S. customers via express mail, addressed to the EP/Cardiology Lab and Risk Management Office, respectively.
The Release Note provides tips for the avoidance of potential events when working with the EP-SH UTTLE, STOCKERT 70, STOCKERT J50 or STOCKERT J70 RF generators with SW versions 1.035 / 1.035J /1.035J70 to 1.037/1.037J70.
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
Excimer laser system - Product Code LZS
Cause
Reports of lower success rates with iris registration (ir) image capture with the star s4 ir excimer laser system v 5.3 that with previous version.
Action
Abbott Medical Optics (AMO) sent an "ADVISORY NOTICE" dated July 18, 2011 to all customers using the AMO WAVESCAN Wavefront System. The letter identifies the product, problem, and actions to be taken by the customers.
The letter instructs customers to create a separate patient file for each eye on the WAVESCAN System (STAR S4 IR Excimer Laser Systems,software versions 5.00-5.30) according to the directions in attachment A. Additionally, customers are to complete and return an attached form to AMO via fax at the regional fax number.
Contact an AMO representative for questions regarding this notice.
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
Excimer laser system - Product Code LZS
Cause
Reports of lower success rates with iris registration (ir) image capture with the star s4 ir excimer laser system v 5.3 that with previous version.
Action
Abbott Medical Optics (AMO) sent an "ADVISORY NOTICE" dated July 18, 2011 to all customers using the AMO WAVESCAN Wavefront System. The letter identifies the product, problem, and actions to be taken by the customers.
The letter instructs customers to create a separate patient file for each eye on the WAVESCAN System (STAR S4 IR Excimer Laser Systems,software versions 5.00-5.30) according to the directions in attachment A. Additionally, customers are to complete and return an attached form to AMO via fax at the regional fax number.
Contact an AMO representative for questions regarding this notice.
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
Excimer laser system - Product Code LZS
Cause
Reports of lower success rates with iris registration (ir) image capture with the star s4 ir excimer laser system v 5.3 that with previous version.
Action
Abbott Medical Optics (AMO) sent an "ADVISORY NOTICE" dated July 18, 2011 to all customers using the AMO WAVESCAN Wavefront System. The letter identifies the product, problem, and actions to be taken by the customers.
The letter instructs customers to create a separate patient file for each eye on the WAVESCAN System (STAR S4 IR Excimer Laser Systems,software versions 5.00-5.30) according to the directions in attachment A. Additionally, customers are to complete and return an attached form to AMO via fax at the regional fax number.
Contact an AMO representative for questions regarding this notice.
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
Excimer laser system - Product Code LZS
Cause
Reports of lower success rates with iris registration (ir) image capture with the star s4 ir excimer laser system v 5.3 that with previous version.
Action
Abbott Medical Optics (AMO) sent an "ADVISORY NOTICE" dated July 18, 2011 to all customers using the AMO WAVESCAN Wavefront System. The letter identifies the product, problem, and actions to be taken by the customers.
The letter instructs customers to create a separate patient file for each eye on the WAVESCAN System (STAR S4 IR Excimer Laser Systems,software versions 5.00-5.30) according to the directions in attachment A. Additionally, customers are to complete and return an attached form to AMO via fax at the regional fax number.
Contact an AMO representative for questions regarding this notice.
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
Excimer laser system - Product Code LZS
Cause
Reports of lower success rates with iris registration (ir) image capture with the star s4 ir excimer laser system v 5.3 that with previous version.
Action
Abbott Medical Optics (AMO) sent an "ADVISORY NOTICE" dated July 18, 2011 to all customers using the AMO WAVESCAN Wavefront System. The letter identifies the product, problem, and actions to be taken by the customers.
The letter instructs customers to create a separate patient file for each eye on the WAVESCAN System (STAR S4 IR Excimer Laser Systems,software versions 5.00-5.30) according to the directions in attachment A. Additionally, customers are to complete and return an attached form to AMO via fax at the regional fax number.
Contact an AMO representative for questions regarding this notice.
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
Excimer laser system - Product Code LZS
Cause
Reports of lower success rates with iris registration (ir) image capture with the star s4 ir excimer laser system v 5.3 that with previous version.
Action
Abbott Medical Optics (AMO) sent an "ADVISORY NOTICE" dated July 18, 2011 to all customers using the AMO WAVESCAN Wavefront System. The letter identifies the product, problem, and actions to be taken by the customers.
The letter instructs customers to create a separate patient file for each eye on the WAVESCAN System (STAR S4 IR Excimer Laser Systems,software versions 5.00-5.30) according to the directions in attachment A. Additionally, customers are to complete and return an attached form to AMO via fax at the regional fax number.
Contact an AMO representative for questions regarding this notice.