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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 archived checkbox.
Displaying 1 - 15 of 686 items.
Digital Diagnost C90
Operators may see an incorrect orientation of images during the first exam upon system start. due to an issue in the firmware of the wallstand vs2 board, the system will rotate the amplimat field selection by 90 degrees. The anatomic position markers…
RecallHealth product recall | 2022-06-13
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
Soltive Superpulsed Laser Ball Tip Fiber Single Use
Olympus has received a limited number of complaints that the laser fiber size on the label did not match the product's size. These complaints were identified by users during preparation for use. Olympus investigations confirmed…
RecallHealth product recall | 2022-06-07
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
Bond Wash Solution
Leica Biosystems recently received a complaint for cloudy bond wash, batch bw102621. The IFU states that turbidity of the solution indicates contamination and/or instability of the diluted wash solution. The functional testing was rerun and passed,…
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
HYGENIC Dental Dam Forceps, p/n H01262 (2020-05-21)
HYGENIC Dental Dam Forceps, p/n H01262 (2020-05-21)
Starting date:
May 21, 2020
Posting date:
June 19, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical…
RecallHealth product recall | 2020-06-19
Elecsys Insulin & total P1NP (2020-05-13)
Elecsys Insulin & total P1NP (2020-05-13)
Starting date:
May 13, 2020
Posting date:
June 19, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device…
RecallHealth product recall | 2020-06-19
Syngo.via (2020-06-03)
Syngo.via (2020-06-03)
Starting date:
June 3, 2020
Posting date:
June 19, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:…
RecallHealth product recall | 2020-06-19
Cardinal Health NPWT 300cc Canister With Gel (2020-06-05)
Cardinal Health NPWT 300cc Canister With Gel (2020-06-05)
Starting date:
June 5, 2020
Posting date:
June 19, 2020
Type of communication:
Medical Device Recall
Subcategory:…
RecallHealth product recall | 2020-06-19
"Ysio Max, Luminos DRF Max, Uroskop Omnia Max & Multitom Rax (2020-04-28) "
"Ysio Max, Luminos DRF Max, Uroskop Omnia Max & Multitom Rax (2020-04-28) "
Starting date:
April 28, 2020
Posting date:
June 5, 2020
Type of communication:…
RecallHealth product recall | 2020-06-05
Cobas p 671 (2020-04-29)
Cobas p 671 (2020-04-29)
Starting date:
April 29, 2020
Posting date:
June 5, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard…
RecallHealth product recall | 2020-06-05