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.
Notes supplémentaires dans les données
Cause
In the service mode the "source alignment procedure" can be started with the door physically open as well as with the doorswitch on linac. this could potentially expose the operator to radiation.
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.
Notes supplémentaires dans les données
Cause
Troponin i results in the cardioimmune xl control are measuring approximately 15-30% low in levels 1 and 3 resulting in control measurements which are outside the published value assignment ranges. as a precaution we are proactively recalling all levels associated with lot cxl1301. only troponin i control measurements are affected all other control analyte measurements are recovering within the published value assignment ranges. we are currently investigating the root cause.
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.
Notes supplémentaires dans les données
Cause
It was recently determined that guidewires within the affected lots of sv-5 and sv-8 peripheral steerable guidewires may have a potential for guidewire fracture resulting in tip separation.
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.
Notes supplémentaires dans les données
Cause
Customers reported vial-to-vial variation of b-type natriuretic peptide-32 (bnp-32) and creatine kinase-mb (ck-mb) recovery in cardioimmune xl level 1 part number cai-xl 1 lot number cxl16011. within the same kit some vials would recover consistently within the range of published value assignment but other vials would recover dramatically outside the value assignment range (higher for bnp-32 and lower for ck-mb).
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.
Notes supplémentaires dans les données
Cause
Baxter corporation has issued an important product information communication to advise customers regarding changes that are being made to instructions for use (ifu) for various baxter pd (peritoneal dialysis) transfer set product codes. baxter is updating these ifus to improve product labeling and ensure consistency of information across the baxter transfer set product family. see also recall number 82892.
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.
Notes supplémentaires dans les données
Cause
The pain pump 2 blockaid demonstrates a defect in battery contact which causes the power to be lost momentarily. a decrease in power (voltage) initiates an e4 error message incorrectly.
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.
Notes supplémentaires dans les données
Cause
Recall initiated due to concerns that the head on the silver care junior toothbrush may detach from the handle.
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.
Notes supplémentaires dans les données
Cause
Blood contamination of internal components of hemodialysis equipment may create the potential for patient to patient cross 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.
Notes supplémentaires dans les données
Cause
When injection parameters are simultaneously prgrammed at boththe main and auxiliary consoles mis-synchronization may result in a variance between intented injection parameters/programmed and deliver.
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.
Notes supplémentaires dans les données
Cause
If the end user does not follow agfa's recommended xa measurement calibration technique the resulting calibration may result in an imprecise xa measurement being obtained.
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.
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.
Notes supplémentaires dans les données
Cause
Potential occlusion (partial or total) of the set of the arterial (red) connector to the dialyzer which could pose a risk of hemodialysis to 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.
Notes supplémentaires dans les données
Cause
The recall is an extension of recall #30400 due to additional lots of the product have received additional complaint reports of pet ring coil breakage. could lead to bowl perforation or chronic enteric fistulas.
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.
Notes supplémentaires dans les données
Cause
Ortho clinical diagnostics inc. (ocd) initiated this recall due to the potential for an increase in u90-382 or 6lu condition codes (wash errors) when using vitros calibrator kit 9 lot 0954. when a u90-382 or 6lu condition code occurs the vitros system suppresses the result and no result is reported. the increase in condition codes primarily occurs when using vitros dgxn and phyt slides. all numerical results obtained are valid providing that no wash errors occurred and quality control results were within acceptable limits.
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.
Notes supplémentaires dans les données
Cause
Intuitive surgical has found that compact flash cards used in touchpads on specific da vinci si and xi surgical systems have the potential to become corrupted when the touchpads experience an abrupt power loss and/or are powered on and off within a short period of time.
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.
Notes supplémentaires dans les données
Cause
Customer information notice being sent regarding notes on workflow for saving patient information in the database.
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.
Notes supplémentaires dans les données
Cause
Users can overfill the supplies drawer (aluminium foiled alcohol pads) which can result in a shorting of the dc adaptor & batteries that can heat up & cause the plastic compartment to melt or battery leakage.
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.
Notes supplémentaires dans les données
Cause
Product may have an open seal in the primary foil package which could result in microbial contamination and loss of suture strength.
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.
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.
Notes supplémentaires dans les données
Cause
Manufacturer has confirmed a recet curve shift resulting in high recovery of qc and patient samples.
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.
Notes supplémentaires dans les données
Cause
Users of these product lots may experience an elevation in the rate of false positivity when compared with previous 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.
Notes supplémentaires dans les données
Cause
Siemens healthcare diagnostics has identified issues with the advia? centaur xpt system software v1.0.1 (bundle 1.0.912 smn 10819704) v1.0.2 (bundle 1.0.1086 smn 11219806) and v1.0.3 (bundle 1.0.1108 smn 11220781) that may affect the operation and workflow of the system. issues 1-12 will be corrected in software version 1.1 (bundle 1.1.243 smn: 11221979) which will soon be available for installation on all systems. the actions to be taken section indicates if the specific issue is corrected in v1.1. for issues corrected in software version 1.1 the actions do not need to be performed after the system has been upgraded to software version 1.1. issues 13-20 will be corrected in future software versions.
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.
Notes supplémentaires dans les données
Cause
This recall is being initiated because the last hole on the veptr caudal rib supports subject to this recall may be partially formed. fully lengthening the construct to the partially formed last hole may result in mechanical failure of the construct due to extension bar breakage which could require unplanned surgical intervention to exchange components. in addition to the risks inherent to re-operation potential effects on the patient could also include pain loss of deformity correction and/or soft tissue/visceral injury.