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
Complaint was received reporting incorrect typing result when using reli sso hla-b typing kit with known sample which had been high resolution ssp typed as b*51 & b*4038. possible false negative with probe 45 gave reli sso result b*51 & b*4001. this problem will also affect b*0835 b*4814 b*5163 and b*5532. the labeling of the affected kits incorrectly includes a high resolution listing for these five rare alleles.
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 software anomaly that occurs with two patients in the queue that could results in wrong patient data recorded in the treatment session.
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 are two scales laser marked on the 6-65mm depth gauge and they are different from each other by 2mm. adequate fixation may not be obtained because the screw selected may be shorter than desired.
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
Due to a software anomaly the camera may intermittently shut off causing a loss of fluoroscopy resulting in an interruption of the examination.
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
Zimmer is initiating this notification due to the discovery of persona tibial articular surface provisional (tasp) shims with missing ball bearings. repeated cycles using sonic cleaning can break down the ball bearing retention feature (swage) on the shim. to prevent this from occurring persona tasp shims must be manually cleaned and inspected per product insert 87-6203-991-22.
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
Philips has become aware that a component of the mrx processor board may be susceptible to damage from electrostatic discharge (esd). damage to these components can disrupt ecg and spo2 functionality leading to an inability to perform: - demand mode pacing - 12 lead ecg acquisition and analysis - ecg monitoring via leads - pulse oximetry (spo2) the presence of this condition will be displayed on the ready for use (rfu) indicator as a solid red x with periodic audio chirp. defibrillation fixed mode pacing ecg monitoring via pads/paddles and other monitoring functions are not impacted by this issue.
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.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notas adicionales en la data
Causa
Issue 1: the user is not able to turn off the pump when a pump in a distal occlusion paused state is exposed to a second "power off then on" malfunction. issue 2: when the user accesses the preventive maintenance screen in service/biomed mode on plum 360 v15.10.00.010 devices with a total delivery time greater than 1500 hours the user will not be able to interact with the device and the device must be power cycled.
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 holding the rails on the easy compression system (ecs) assembly were not appropriately tightened and could create a potential hazardous situation if the c-arms were to fall.
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
Malfunctions on roller pumps and centrifugal control module include distorted display difficulty to turn speed knob and loss of local control or display.
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
Non-compliance of the labeling information on the outer container. the outer container from this particular lot (d607082) did not contain the device identifier.
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
Bausch & lomb had become aware that it is possible to generate particulate from the plastic needle wrench when attaching the needle to the hand piece. type of injury would be a foreign body reaction.
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
Due to customer complaints reporting that the double swivel connector may crack or separate on the endobronchial tube. should this occur the device may leak causing a risk of respiratory distress or hypoxia that can in some cases lead to the need to re-intubate 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
Two issues affecting the monaco device: 1) when ct images are created this latter way and imported in monaco the image is displayed correctly but the electron densities are incorrecly flipped in both the right-left and superior-inferior directions. 2) when using multiple prescription and the first prescription has forced densities these forced densities are not being maintained with the second prescription.
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
Inadequate cooling could cause the ultrawand lp to overheat and damage cardiac tissue.This potential exists when the ultrawand lp is run using off-label cooling methods (e.G. gravity saline flow instead of iv pump) or when cooling flow to one or both cells is decreased which may occur as a result of pressure applied by the physician to the device.
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
Use of these particular mattresses in combination with invacare beds and bed rails may put users at increased risk of entrapment.
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
This is an extension of a previous recall including more models with the increased liklihood of focal neckdown (narrowing) of the balloon deflation lumen which could result in a no-deflation condition.
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 affected packs contain a 10-cc syringe with a flange that is too large to fully lock into the syringe adapter.Complaints have been received for syringe will not fit in collar or falnge too long.
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
Drop in recovery on lithium for a number of lot numbers. residual effects of the above reagents have caused contamination of the fluid pathways and negatively conditioned the li sensor.