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Please note: using the search filters may not provide accurate search results for records prior to November 2021. When searching for older records, please ensure that you use the include archive checkbox.

Displaying 1 - 6 of 6 items.

" " Nucleus 7 Processing Unit
This failure mode has potential to manifest for all devices manufactured with apple MFi keys in the range 6100 to 6103 when attempted to pair with iOS devices. Complaints to date have come from CAM, APAC and EMEA regions. This issue is isolated to cp1000…
RecallHealth product recall | 2022-06-13
" " Pagewriter Electrocardiograph
The pagewriter tc30/50/70 cardiograph device could potentially fail to charge while plugged into the ac power outlet. This is due to a faulty mainboard. based on a supplier analysis, the faulty mainboard was caused by…
RecallHealth product recall | 2022-05-30
" " Temperature Probes
The esophageal/rectal/skin temperature probe's instructions for use, (IFU), contain inadequate instructions related to the cleaning and disinfection process for the reusable probes. The IFU instructs the user to clean the product with disinfecting agents…
RecallHealth product recall | 2022-02-21
" " LiquiBandFIX8® Open Hernia Mesh Fixation Device
During verification testing, a non-conformance was detected. Failure mode was uncontrolled leakage of glue from the distal tip of the Fix8 Open (FX002) device. Recall start date: Feb 3, 2022
RecallHealth product recall | 2022-02-11
" " CA-N95 FLAT FOLD RESPIRATOR
Respirator requires a disclaimer that it is not NIOSH N95 and to include a unique identifier for each model on the packaging.   Recall start date: 2021-10-27…
RecallHealth product recall | 2021-11-22
" " VIDAS Protein C & TOXO IGG Avidity
Based on an unusual rate of complaints from the field for "Substrate error" leading to a potential delayed results on different  References tested on all  Systems, Biomerieux initiated an investigation. The substrate error…
RecallHealth product recall | 2021-11-05
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