🏥 Medical Devices • 15,809 recalls
Zap Surgical Systems
Software issue identified in cases of initial patient setup with large (greater-than-or-equal-to 1.5 degrees) rotational deviations, between digitally reconstructed radiographs, and pre-delivery X-ray images. In these cases the transitional alignment algorithm may incorrectly calculate the new treatment table offset values, leading to an incorrect position for the subsequent treatment isocenter.
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching
FUJIFILM Healthcare Americas
Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruction, thereby exposing the patient to additional radiation
Aniara Diagnostica
Incorrect product labeling was included in the package.
Baxter Healthcare
Firm noted an increase in customer reports of leaks.
FUJIFILM Healthcare Americas
Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruction, thereby exposing the patient to additional radiation
Qiagen Sciences
During the "Load tip racks and enzymes" step of the run set-up, the info screen indicates "minimal volume to be loaded", but the indicated volume is instead the exact volume that should be loaded. Misunderstanding the guidance may lead to over diluted, under diluted, or improperly lysed sample, which in turn could lead to false negative or false positive results.
ICU Medical
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
FUJIFILM Healthcare Americas
Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruction, thereby exposing the patient to additional radiation
Mako Surgical
Certain units have the potential to exhibit infant failures whereby units either arrive non-functional, have the potential to become non-functional, or flash an error light while in use.
American Contract Systems
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
American Contract Systems
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
American Contract Systems
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
American Contract Systems
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Stradis Healthcare
Potential for incomplete seals.
American Contract Systems
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
American Contract Systems
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
American Contract Systems
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
American Contract Systems
Product was exposed to multiple sterilization cycles without validation for multiple exposures.