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
All scan windows that consist of the material "makrolon" need to be exchanged in the field due to the aging effects of both the material and bonding material.
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 manual cleaning instructions for these products require updates to ensure proper cleaning prior to sterilization steps.
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
Contamination in a subset of vials of vysis lsi atm/p53 and d13s319/cep 12/13q34 probes with lsi atm sg/p53 so probe.
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 supplier w&h dentalwerk burmoos notified cbas of a potential malfunction in the foot control included in osscora surgical set (part# 91053). foot control may not switch back to zero position when pedal is released-causing motor to continue rotation. drilling mode not affected. automatic torque stop fully functional.
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 check valve in certain ventricular or lumbar external drainage sets may be stuck in the closed position.
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
One lot of snaplink buccal tube brackets has been mislabelled. l6l snaplink brackets (part no. 438-2191) are incorrectly labelled as l6r snaplink brackets (part no. 438-2190). the l6l bracket is correctly packaged in a yellow tray has a yellow id dot to indicate a distal/gingival location and the hook orientation is intended for left distal placement.
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 product label is in english only and does not include the required french text as per health canada medical or device regulations section 23 (3).
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 healthcare received a report from a customer that during a system start-up operations (powers up) when the power of the gantry and ct host has been powered off) the e-stop (emergency stop that halts all scanner and table motions and x-ray generation) failed to close.
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
An internal technical investigation has confirmed that legionella pneumophila 2-14 reagent lot: 1265366 may return false negative results. this reagent is contained within the following products: oxoid legionella latex test (dr0800m) lots 1314413 and 1301907. continued use of these lots may result in a delay to the correct serogroup characterisation of legionella isolates.
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 found a slight change in performance indicated by prolonged aptt results.
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 number of the amh gen ii elisa test kits lot number 219520 were packaged with the incorrect wash concentrate. these kits were packaged with wash concentrate b (ref dsl-10-9730) instead of wash concentrate i (ref dsl-10-4030).
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 ec certificate of all medical devices from the manufacturer silimed who is a subcontractor to coloplast has been temporarily suspended by their notified body due to particles found at the surface of some breast implants. there is no indication that these issues would pose a threat to the implanted person's safety. the suspension also affects vaginal stents placed on the market by coloplast. in line with recommendations from the authorities coloplast request that all affected devices with silimed as point of origin should be put in quarantine and that use of these devices should be ceased until further notice.
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
Error in calibrator values can cause over-estimation of results by approximately 10%.
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 determined that some dilution factors configured on the engen laboratory automation system are not supported in the instructions for use for the following 4 ocd vitros products: vitros che slides vitros crbm slides vitros tibc kit and vitros upro slides. to address this ocd will implement a software modification that will remove all non-supported dilution factors on the engen 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
This recall was initiated because ortho was made aware of new information regarding the potential for n-acetylcysteine (nac) to interfere with specific vitros chemistry products slide assays (glu lac trig and uric). patients who were administered nac could potentially have biased sample results.
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 catalogue number etched on the instrument reads "7053-58-20" and it should read "7053-58-10". the incorrect catalogue number corresponds to full blade.
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
To advise all icon users that the autoperfusion 1.3 sw is now available.
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
Gehc has updated the service manuals used to maintain these scanners to fix an incorrect torque value which is the source of the field action. fmi 25463 identified a torque issue with 5 volt supplies in ct and pet lightspeed systems and corrected the issue by field action as well as a technical manual update. this recall is to send a second customer letter to anyone who may still possess and use an obsoleted service manual.
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
To distribute icon 9.5 wholebody spect advisory letter for icon 9.5 acquisition workstations.
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 specific packs of trushape 3d conforming files contain incorrect files. the affected packs are: - reorder number tsfile2021 lot number 0000165147 - reorder number tsfile4021 lot number 0000165153 trushape 3d conforming files size 40 21mm contain files of size 20 21mm. trushape 3d conforming files size 20 21mm contain files of size 40 21mm.
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 the directions for use of the product the sentence " begin the preparation of the pivot using a tarpon (step 3)" assumes the use of the material to obturate the canal a use not supported by evidences.
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
Customer complaints received on two lots of hemosil readiplastin pn 0020301400 reporting imprecision out of range quality controls and prolonged sample results.
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
Upgrade to units to meet iec 6/0950 hazardous energy level regulations.