Complete FDA and NHTSA recall records dated in September 2020.
These records include useful source details for the selected month.
The defect relates to firmware version lower than V02.13.00. It is controlling safety interlocks of the LDI; specifically, the potential for the LDI to enter a service mode intended for use…
When performing offline image review in RayCare 2C, RayCare 3A and RayCare 3B an offline image review task will guide you to the image viewer with the treatment image related to the…
Potential Endotoxin Contamination
Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible…
Potential Endotoxin Contamination
When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results.
The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending,…
Potential Endotoxin Contamination
Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible…
The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending,…
E. CAM and Symbia system with foresight detectors performing gated or dynamic acquisition may lose some detector time information. Our risk analysis indicates that the probability of…
Potential Endotoxin Contamination
Potential Endotoxin Contamination
When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results.
Software defect may result in disapperance of tag sites during recalculation and lead to additional ablation sites. This may lead to prolongation of the procedure and, in extremely rare…
Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides
Potential Endotoxin Contamination
Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after the previous repair of the X-ray Generator with an integrated Energy Storage Unit (ESU).
The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending,…
The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending,…
Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible…
Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible…
Potential Endotoxin Contamination
Traceback investigation into an outbreak of Salmonella Newport illnesses found red onions to be a suspect vehicle for the outbreak. After notification from FDA, firm initiated a recall.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
