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
Incorrect lot number printed on the outer packaging of the cardiac control troponin-t kit. printed lot number is: 173 934-03 and correct lot number is: 176 934-03.
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
An assembly error resulted in a low percentage of test units from these kit lots not containing a coated bead.
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
Concordance error. mechanical abnormality in the rack caused the rack to advance to position 3 instead of 1 resulting in concordance errors. user manual does not address this error.
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 has received reports of magnesium test results with an upward shift from 0.4 meq/l to 2.1 meq/l and can delay treatment for low levels of magnesium.
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 tips had an internal sharp edge caused by moulding burrs. possibility that redness on the skin from too strong a dermabrasion treatment by an inexperienced operator 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.
Notas adicionales en la data
Causa
For the spectra camera interfaces assembled within the kolibri mobile camera stand a long-term reliable fixation of the camera unit cannot be guaranteed due to a manufacturing error.
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
In an occurrence it has been found that when an operator performed an exam with the wireless x-ray detector an error message dialog was displayed on the console. after a system reboot the image data was lost.
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
Water leaks from the micro-temp lt model 749. water leaks are due to cracking of the reservoir's heater plate.
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 an anomaly in the packaging process it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product. the breach may or may not be easily seen.
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 has been a change to the acceptable range for the 'e' calibration coefficient guideline. the new guideline range is 5 to 8 (conventional units). the guideline range for lots prior to ga3099 is 6 to 9. the e coefficient range is a criterion used by customers to assess the validity of their calibration. siemens has also noted that some users are not updating scaler values when setting up a calibration (this was implemented beginning with lot ga3009) resulting in inaccurate values for both patients and controls.
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
3m is notifying all users of the 3m surgical clipper professional 9681 of an added product warning stressing the importance of following proper clipper charging practices as documented in the model 9681 clipper instructions for use.
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
Rapidlab 1265 systems may report invalid co-oximeter values to an lis rapidlink or rapidcomm 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
Ortho clinical diagnostics (ortho) has initiated this recall because ortho has received an increase in customer complaints and has confirmed the intermittent presence of marked hemolysis in ortho reagent red blood cell (rrbc) products as well as quality control products containing red blood cells. ortho conducted an extensive investigation and the root cause for the marked hemolysis has been identified as microbial contamination.
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
Depuy spine is recalling all lots of confidence kit spinal cement system and confidence plus kit spinal cement system following reports that the cement mixer used to prepare cement for surgery may not turn properly. the event may be described as the mixer being jammed or stuck.
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 manufacturer recently received reports of a 'fault in motor controller' alarm message. if this occurs the pump stops and audible alarm sounds and a visual alarm is displayed. the 'fault in motor controller' message is displayed on the system panel. on some occasions the circuit breaker of the pump on the emergency power pack may also trip.
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 potential problem which could result in an early failure of the scissor arm to bracket connection. the failure can be identified by observing the physical condition of the scissor arm bracket. the plastic covers around the bracket typically show signs of fatigue before the bracket actually breaks. this can be an early indicator of a potential problem.
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
It was determined that tonowash devices were being sold to users in canada and that these devices are unlicensed.
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 (ortho) has initiated this recall because it was determined that the open pack (in use) storage limits must be reduced from 8 weeks to 4 weeks for vitros immunodiagnostic products total t4 (tt4) reagent packs. this change affects expired current (in date) and future product lots.
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 healthcare diagnostics has received several reports from customers of one or more electrolyte parameters (e.G. na+ ca++ k+ cl-) reporting a "-----?" error code when aqc qc or cvm is run on the rapidpoint 500 blood gas analyzer. when exhibited the tissue is usually seen during level 1 qc/aqc level 1 cvm and sometimes level 2 cvm testing. this issue has also been observed on a small number of patient samples. this issue impacts only rapidpoint 500 measurement cartridges p/ns 10491447 10491448 10491449 and 10844813. siemens has observed this issue with rapidpoint 500 measurement cartridges with serial numbers up to 2412705915 however not all these cartridges will exhibit this behavior. the issue does not impact rapidpoint 400 or rapidpoint 405 measurement cartridges.
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 issue happens for rf projection images [the 12 dicom sop classes]. if user measures on rf image "cal" (calibration) is not displayed and measurement is not correct. the "cal" label is not displayed on the projection images after calibration is performed which should be present if the measurement is presented based on pixel spacing.
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
Advisory and software upgrade to correct problem with images.
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
False susceptible vancomycin ast results for emerging strains vancomycin resistant e. faecium (vre).
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
Physio-control inc. lifepak 15 monitor/defibrillators with etco2 capability are distributed with the etco2 setting preset to display in mmhg. customers may choose to reconfigure the device to display the etco2 in alternative modes of kpa or % settings. when using etco2 in the kpa or % setting and in a situation where the reading is above 9.9 kpa the display of the lifepak 15 respiratory rate may partially obscure a portion of the leading digit of the etco2 value. although part of the first digit of the etco2 value is obscured by the respiratory rate the capnography waveform scale automatically adapts to the etco2 value. observing the capnography waveform and the range displayed will help the user confirm the patient's etco2 value. clinical interpretation of a low etco2 value when the value is actually high could potentially lead to incorrect treatment. there have been no reports of incorrect patient treatment or harm associated with 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.
Notas adicionales en la data
Causa
The taq polymerase is not amplifying dna as intended. there is suspected contamination that is causing the taq to not work properly. kits which contain the affected lot of taq (taq polymerase vial lot # 864459) are not useable unless a different lot of taq is used.