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.
Notas adicionales en la data
Causa
Dash monitor may show reboots on some networks when 802.11b wireless lan option used to connect to hospital wireless lan infrastructure resulting in loss of patient monitoring patient alarms & vital signs data.
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.
Notas adicionales en la data
Causa
Since launching the segmental system in 2007 zimmer has received 13 complaints related to hyper-extension. this represents a complaint rate of approximately 0.4% since the product was introduced. analysis of the explanted polyethylene insert also found that it typically exhibited anterior deformation in affected patients.
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.
Notas adicionales en la data
Causa
Vista information service pack 3 has a software error that occurs during the eligibility assessment of the donor. the software error will incorrectly estimate the red blood cell product loss as 0 ml.
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.
Notas adicionales en la data
Causa
Recalled pumps contain one of the previous versions of pump application software. as a result users may not be able to program affected pumps to receive glucose values from blood glucose meters provided.
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.
Notas adicionales en la data
Causa
The advia centaur assays listed above show changes in patient samples and quality control values when the ambient temperature of the room or laboratory shifts between 18 c - 30 c where the advia centaur system is installed. these assays are not meeting the specifications within the operating temperature range which is 18 c - 30 c. this effect occurs on either the advia centaur advia centaur xp and/or advia centaur cp systems depending on the assay and the 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.
Notas adicionales en la data
Causa
Specific lots of the o-two adult ventilation timer may malfunction. the flash rate of the malfunctioning device may be much faster than it is labelled with a reported flash rate of 20 per minute instead of the labelled flash rate of 10 per minute.
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.
Notas adicionales en la data
Causa
Screws in the impant sets type s40 produced prior to january 1 2006 may disassemble during surgery. the movable cradle component could detach from the saddle under extreme manipulation of the associated rods.
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.
Notas adicionales en la data
Causa
Manuafcturer has received reports of a limited number of fractures which is acute and may or not be associated with the patient falling or other high load application.
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.
Notas adicionales en la data
Causa
There were reports indicating that the irrigation pump was not functioning. therefore saline would not be provided to the tip. as a result the cooling function would be lost and could potentially cause the tip to heat up potentially resulting in tissue burns to 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.
Notas adicionales en la data
Causa
Under specific conditions the advia 70 system does not transmit alert flags when the automatic transfer option is enabled.
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.
Notas adicionales en la data
Causa
A limited quantity of the cmax hand controls were manufactured without loctite thread locker on the screws that attach the mounting clip to the hand control case. it is possible that screws without the loctite can work loose and the clip can become separated from the hand control. if both screws back out completely the internal components of the hand control and/or the table control board may become damaged. this could cause a loss of hand functionality.
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.
Notas adicionales en la data
Causa
Beckman coulter has determined that nonconforming sample probe cables may have been installed on newly manufactured and/or recently serviced unicel dxi instruments. use of a nonconforming sample probe cable can cause a delay in reporting results but will not cause erroneous results. a nonconforming sample probe cable may cause level sense errors. if a level sense error occurs due to a nonconforming cable the test may not start or an in-process test is automatically cancelled.
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.
Notas adicionales en la data
Causa
Ortho clinical diagnostics (ocd) has identified an anomaly with vitros system software version 3.0 and below. internal testing confirmed that when using calibrator barcode labels supplied with vitros chemistry products calibrator kits 1 2 3 4 6 or 9 an unexpected assay calibration may occur if assay targets are unassigned. consignees are being instructed not to use the calibrator barcode labels for vitros calibrator kits 1 2 3 4 6 or 9 until the next version of software is installed on their vitros 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.
Notas adicionales en la data
Causa
Siemens multistix 10 sg (ref 2161) does not have a medical device license in 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.
Notas adicionales en la data
Causa
Some customers have reported receiving product with multiple slices in the white portion of the sterile tyvek header 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.
Notas adicionales en la data
Causa
Over time internal battery begins losing ability to hold a charge resulting in shortened ventilator operation time. specifically there have been reports of shut down with less advance warning than expected.
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.
Notas adicionales en la data
Causa
There have been reports of quality control (qc) shifts with pseudocholinesterase (pche) and imprecision during pche calibration with dimension vista enzyme 1 calibrator (enz 1 cal) lots 3fd034 and 3hd012. investigation by siemens confirms a loss of pche activity in the affected lots of enzyme 1 calibrator causing an elevation of qc by as much as 80% and in some instances imprecision of replicates during calibration.
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.
Notas adicionales en la data
Causa
Hill-rom has received thirteen reports over the past 8 year from facilities in the usa alleging that the affinity four lift-off foot section has fallen resulting in three minor injuries. analysis suggests that the latch mechanism may have been bent due to user error during handling of the foot section such as dropping it to the floor.
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.
Notas adicionales en la data
Causa
Process flaw in circuit board may cause unit to fail to charge or hold its charge above 75 joules.
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.
Notas adicionales en la data
Causa
Manufacturer was aware that lack of irrigation could potentially lead to excessive heat at the tip. overheating of the tip of the sonopet system during surgery could lead to cranial injury in a 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.
Notas adicionales en la data
Causa
Under specific conditions the laboratory system may incorrectly report results of 0 for tests that have not yet been resulted.
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.
Notas adicionales en la data
Causa
Certain lots of statlock arterial stabilization device were inadvertently packaged with the (incorrect) insructions for use (ifu) pamphlet. each carton was packed with the ifu intended for statlock dialysis stabilization device instead of that for statlock arterial ultra device.