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Chemical contamination: product contains elevated levels of undeclared lead.
Convenience kit mislabeled with the incorrect catheter effective length on the device label and the packaging label. Use may lead to a delay or interruption of treatment and user dissatisfaction or annoyance.
The motor controller may fail, which can potentially lead to an error in functionality of the Body Weights Support Rope, which means that the rope can go up or down in an uncontrolled way.
Ford Motor Company (Ford) is recalling certain 2011-2014 Fiesta, 2013-2014 Fusion, 2015 Mustang, 2013-2015 Escape and C-Max, 2012-2015 Focus, 2014-2016 Transit Connect, 2013-2014 Lincoln MKZ, and 2015 MKC vehicles. These vehicles were previously recalled and repaired under recalls 15V-246, 16V-643 or 17V-210, however the repair may not have been completed properly. A component within the door latches may break making the doors difficult to latch and/or leading the driver or a passenger to believe a door is securely closed when, in fact, it is not.
There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check", EffectivCRT" algorithms, and AdaptivCRT"). This rare interaction results in temporary suspension of automatic threshold testing and output adjustments, and suspension of auto-optimization of CRT therapy. The issue is unlikely to result in clinical impact to the patient, and features are restored upon next programmer device interrogation or presence of a magnet.
When using Sample Transfer protocol version 3.0, the drop catcher is not activated on the MagNA Pure 96 instrument, which introduces a potential risk for cross-contamination leading to erroneous results.
The Substrate Monitoring System in the AIA-900 Analyzer did not detect an empty substrate bottle. The issue may lead to erroneous immunoassay test results.
Unexpected interface driver behavior identified (QC) Results May Be Assigned to an Incorrect Control Lot Number, and lead to the reporting of erroneous patient results if the QC failed but appeared to be passing and the issue is not detected during QC review