Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
A product defect named "lip-out" was detected for bd vacutainer pst tubes. it consists of gaps of various sizes in the structure of the tube wall that is present at the lip of the tube. these gaps are covered by the stopper and hemogard closure so the tube can be evacuated and used for blood collection. customer complaints cite jamming of preanalytical automation (tube decappers) and leakage of blood in the specimen transport bag.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
The expery date printed on the box label mentions a shorter expiration date compared to the expiration date printed on the tube label (7 months difference).
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
The tracheal tube can kink during patient use. if a tracheal tube kinks it can cause decreased oxygen saturation and require re-intubation of the patient.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
Quality assurance dates could not be entered after 2003/05/19.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
Philips will be providing a software upgrade to brightview wct system customers to improve the functionality of the device and correct several issues that either have no identified hazards or have been determined to have minimal risk.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
When using the copy and paste features of the software the treatment fields are not automatically updated and could lead to a misadministration of dose.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
Some of the kits may have speckled coat on the oval test and reaction may appear as a weak positive due to the granular specks.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
Ge healthcare has become aware of a potential issue associated with the hand grip that is clamped to the table top of your revolution xr/d x-ray systems that may impact patient safety. the hand grip accessory that is clamped to the table top may not be properly adjusted and can dislodge during use. should this happen during patient loading or unloading patient injury could occur.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
This recall supersedes teleflex's march 4 2011 communication. teleflex medical is withdrawing the rusch irrigation trays catalogue number 67890 and 68895 from the market. these trays contain alcohol prep pads recalled by triad due to concern about bacterial contamination and . all trays containing the alcohol prep pads recalled by triad should be returned to teleflex medical.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
Additive content labelon bd microtainer tubes is incorrect for the bag and case carton. the graphics indicate that the additive is sodium fluoride / potassium oxalate. the actual is sodium fluoride/na2edta.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
A false reaction maybe observed with the mica019 antigen. upon investigation trnsfected mica 019 cell lines (rc1223) demonstrated a lack of or presence of recombinant mica019 inserts.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
Ge healthcare has recently become aware of a potential safety issue that can result in a scan starting before the prescribed delay has completed. more specifically if an exam is interrupted during the prep delay period using the emergency stop button and the scan is then resumed the delay period may be shorter than expected. if personnel are in the scan room at the time of the premature scan initiation they can be exposed to scatter x-ray radiation.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
Philips has become aware of several software issues which will be corrected with the release of a new software version. problem 1: when positioning for a relative 180 degree non circular acquisition the second (bottom) detector was not positioned correctly by an operator causing an inappropriate rotation orbit calculation for the patient being imaged. when the acquisition was started and the detectors began to move into position the incorrect calculation resulted in the detectors coming in contact with the patient. problem 2: on separate occasions as the gantry system was moving to a relative 90 scan position of the detectors a patient or operator moved their hands or arms into the path of the detectors in the area of where the detectors meet resulting in the detectors coming in contact with the patient and operator. problem 3: while a user was manually positioning the patient for their exam and translating the pallet into the gantry bore the pallet catcher that supports the imaging table was higher than the imaging pallet resulting in a pinch point or table tilt if not engaged with the catcher. this problem can only occur on the brightview x or the brightview xct system.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
Within the sureloc application under sureloc preferences there are two grid options: a generic grid or the ge 8-channel curved grid. a generic grid is a flat grid of 2 centimeter holes. there is no limitation on the number of blocks.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
The positive control is not consistently producing the expected results described in the package insert.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
Patients may show discrepant results when tested with the assay kit (value < lod or values < ldl) due to a nt-probnp genetic variant. as a consequence the manufacturer will update the method sheets accordingly in the limitations-interference section.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
Manufacturer is issuing a notice to all users on two issues 1)specific keystrokes sequence can result in over-infusion 2)to safeguard the security codes that allow programming pump parameters.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
One of the 3 pins to hold an alignment block to the floor of the mr suite was missing until during testing on the weekend the missing pin was pulled into the magnet damaging the image quality phantom andheadrest extension.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
There is an increase in "stuck in sheath" reports involving the use of the superarrowflex (wire-reinforced) sheath with the iab-058xx catheter series. when the iab becomes stuck in the sheath the user is unable to move the iab catheter forward or backward potentially causing a delay in this critical therapy.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
Response wire diameter description listed on the invoice did not match the descriptor listed on the packaging.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
Ocd has issued a recall pertaining to a potential malfunction in a wire connector used in the vitros 4600 vitros 5600 and vitros 51 fs systems that were shipped during a specific date range. to date six customers reported the smell of melting plastic or observed smoke originating from their vitros 4600 and 5600 systems. although reports are confined to the vitros 4600 and 5600 systems the same wire connector is also used on vitros 51 fs systems. as a precaution ocd is contacting customers to notify them of this potential malfunction for vitros systems that were shipped during a specific date range.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
The plastic coating of the stylet may split and/or break off of the stylet. this may result in a piece of plastic totally or partially occluding the patient's airway and impairing ventilation or necessitating invasive removal procedures in order to prevent complications such as atelectasis or pneumonia.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
Potential for the kit control 1 and 2 to recover low of the established range.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
The manufacturer has determined that listed products may possess levels of endotoxin that exceed regulatory limits. mcp has become aware that its sampling plans for endotoxin testing on products labeled "non-pyrogenic" were not compliant with usp requirements for endotoxin on medical devices and ansi/aami st72: 2011 bacterial endotoxins - test methods routine monitoring and alternatives to batch testing. while maquet has not received any complaints of adverse events related to endotoxin exposure maquet cannot ensure devices labeled "non-pyrogenic" are without endotoxin based on a statistically valid sampling plan.