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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
The VITROS XT 7600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.
The VITROS 5600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
During the assembly of the cartridge to its connecting body part, the valve may open prematurely resulting in partial or complete emptying of the cartridge before its intended use.
The VITROS 3600 Immunodiagnostic System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.
Potential for signal drift in specific lots of BD PCR Cartridges.
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an analysis step being disabled with the monitoring service application software.