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.
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Reason
Covidien informs of a potential failure of audible backup alarms in the event of power loss to the ventilator legendair.
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.
Extra notes in the data
Reason
Non-safety relevant features related to blood flow management during the disconnect mode and the re-connect mode after recirculation were not included in the software (version 6.00.01) of the device as specified.
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.
Extra notes in the data
Reason
Premature battery depletion and/or prolonged charge time may occur in a limited number of alto implantable cardioverter defibrilator.
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.
Extra notes in the data
Reason
Version 1.5 of the sway balance app released on january 22 2014 was incorrect and displayed artifically high and erroneous sway balance scores.
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.
Extra notes in the data
Reason
An error in the directions for use in section 1 step 1.3. the correct direction is that users should not remove the protector from the patient line connector on the set prior to connecting solution bags.
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.
Extra notes in the data
Reason
Ge healthcare has recently become aware of a potential safety issue associated with the loosening of the blender knob shaft on all resuscitation units. a loose blender knob shaft may potentially affect the accuracy of the blended output of air/o2 gas mixture from the unit.
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.
Extra notes in the data
Reason
Measurements allowed on mpr's (multi planar reconstruction quadrants of 2d images) acquired with a 3d free hand sweep which are converted to clips. should not be allowed due to the inaccurate spatial geometry.
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.
Extra notes in the data
Reason
Quality control (qc) results without a qc specimen id (sid) are being filed with patient results that follow it in the same message on instrument manager siemens dpc cirrus lmmulite/lmmulite/versacell (dpcimmui) driver. if the cirrus lmmulite lmmulite one lmmulite 1000 lmmulite 2000 lmmulite 2500 or lmmulite xpi instrument is running in uni-directional mode and is configured to automatically send qc results to the laboratory information system (lis) and specimen ids are not added to qc samples then qc results received by im without a specimen id will be added to the first specimen received after these qc results in the same astm message.
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.
Extra notes in the data
Reason
Capture-r ready-screen and ready-id test wells that are present in a plate frame during process steps but not used for testing have a possibility of negative or weaker reactions when used for testing.
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.
Extra notes in the data
Reason
There is a potential for either the head section or the foot section of the bed to drop unexpectedly if preventive maintenance of the screw box has not been conducted.
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.
Extra notes in the data
Reason
Specified lots of sprayed ha stems produced did not meet stryker's internal material specification for tensile bond strength and crystallinity.
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.
Extra notes in the data
Reason
There is a potential for peeling and melting of the insulation of the cautery tip of the ima / ent blade electrodes. this can result in the tip losing integrity leading to sparking or arcing of the current at the blade tip and result in a burn or electrical shock.
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.
Extra notes in the data
Reason
Software update to address 1) unexpected shutdown and device restart of the touchscreen resulting in settings returning to those stored in the clinic configuration of the device and loss of manual settings and 2) the possibility that electromagnetic interference due to electric current fluctuations may cause pressure values on the display to freeze.
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.
Extra notes in the data
Reason
An anomaly was discovered in which under certain circumstances of control circuit adjustments and component failure a c-series clinac can beam on with an asymmetric electron beam which is undetected by the interlocks intended to prevent it. the anomaly can occur in the rare event a balance potentiometer in the electron programming pcb fails and the other circuit settings are such that the effect is not detected.
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.
Extra notes in the data
Reason
The innova system can unexpectedly stop delivering x-rays after a power-on or a reset cycle which may result in the loss of real-time interventional imaging. no injuries have been reported due to this issue. the innova system can unexpectedly stop delivering x-rays after a power-on or a reset cycle which may result in the loss of real-time interventional imaging. no injuries have been reported due to 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.
Extra notes in the data
Reason
A few products had labels with wrong symbols indicating the degree of protection against electric shock.
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.
Extra notes in the data
Reason
Philips has become aware of the following seven software issues: 1.Sagittal result shortened for axial scans 2.Single series displayed in console viewer when creating mpr's. 3.Scan length changes with a change in field of view 4.Different ctdi values with doseright 5.Scan length changes on subsequent axial results 6. surview scan lengths near 135mm or 184mm may result in unexpected scan start positions and 7.Reconstruction length does not equal scan length.
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.
Extra notes in the data
Reason
There is a potential of an unsecured mechanical detent marker of the dx-d 600 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.
Extra notes in the data
Reason
Pentax america inc. is issuing new instructions for use (ifu) for two rigid laryngostroboscope models 9106 and 9108. this new ifu clarifies the reprocessing instructions in order to ensure that customers are aware of the best methods for cleaning their 9106 and 9108 endoscopes. to ensure all customers have updated information these new ifus are being sent to all customers who have purchased.
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.
Extra notes in the data
Reason
A pinhole in the end of the blue protector cap due to a molding anomaly which could allow a steady stream of fluid to exit during priming.
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.
Extra notes in the data
Reason
The x-drive assembly is used in the m2000sp and m24sp instruments. according to x-drive assembly supplier on one of the two processing machines where the steel wire is pretreated and primed the wire was polluted by rusty pulleys. consequently belts produced from this machine between 01/01/2013 and 09/30/2013 contain rusty wires. under stress such as routine use of the instruments this issue can lead to damage of the belt. after days weeks or sometimes months of operation the belt tension can become weak causing an unusual rattling noise or misalignment.
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.
Extra notes in the data
Reason
Beckman coulter has determined that when the maintenance log for december is printed or savedentries for the subsequent eleven (11) months are lost and cannot be retrieved unless the database was backed-up prior to performing the print or save actions. for example if december 2012 is printed or saved any maintenance log entries for january-november 2013 will be lost. this issue can result in potentially incomplete maintenance log entries. no other report generator functions or patient results are affected 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.
Extra notes in the data
Reason
Oxygen flow sensor exhibited premature drift in accuracy prior to its end of life date.
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.
Extra notes in the data
Reason
Customer complaints were received showing a slightly increased frequency of positive results in the close cut-off range therefore false positive results in the weak positive range cannot be excluded.