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The pressure relief valve may fail to open properly.
Wrong component may result in over infusion of medications.
With maintenance of the STA line, the cap-piercing feature may involve potential risk of needle puncture injury.
Software defect; potential under certain circumstances to incorrectly identify endoscopy images that have been uploaded & saved to the network system.
The IMx AFP Calibrators may cause depressed values for the IMx AFP Low Control, and cause patient results to be 20% lower than actual values
Product infuses too fast at rate of 30 minutes instead of 2 hours. Component mix-up.
Incorrect patient information is displayed in the reconstructed images of a whole body patient scan.
The CA 15-3 Calibrators may cause depressed values for the CA 15-3 High Control and for patient specimens.
software issue. New examinations may not be saved properly and the examination may be lost.
Patient results do not update properly when modified using on-line entry function.
Mislabeled product: Screw length incorrectly labeled may contain a 20 mm instead of 30 mm.
Mislabeled product: Screw length incorrectly labeled may contain a 20 mm instead of 30 mm
Mislabeled product: Screw length incorrectly labeled may contain a 30 mm instead of 25 mm
software problem This error may cause the loss of peripheral image information when there is a difference between the dimensions of the image matrix and the display segment.
Mislabeled product: Screw length incorrectly labeled may contain a 30 mm instead of 20 mm
software problem - erroneous results or system crashes