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The bed may drop due to a malfunction of the actuator exceeding its stop.
Modification to labeling for surgical implant.
Incorrect length leg pin bolts may cause patient lift failures
Failures within the PCA profile as well as incidents resulting in interruptions of therapy in various profiles.
The preservative sodium azide used in the Kit Negative Control (part number FCOM175) was at the wrong concentration - the Kit Negative Control contains 0.2% sodium azide rather than the intended 0.1%.
The bit may bend or fracture during use.
To correct a software problem that caused the LV images, which were acquired for 15 seconds at the end of the examination, to be lost.
These specific protein assays are not meeting the 57-day on board stability claim
Incorrect patient blood glucose test results may be reported due to a software problem.
Pulmonetic Systems has identified the potential of a printed circuit board malfunction, which can result in a ventilator malfunctio (e.g. Vent INOP, HW Fault, Xducer Fault) and possibly resulting in failure of the ventilator to breathe for the patient. This malfunction may occur without an accompanying audible alarm.
Alsius has found that fluid spills or ingress may result in an alarm condition. The potential health risk involved in this state can be the discontinuance of therapy.
The ulnar bearing may damage the implant's polyethylene sleeve such that revision surgery is necessary.
Mislabeled boxes -- Scorpio PS Right Femoral Component No Posts contained a Scorpio PS Left Femoral Component with Posts and vice versa.
Possible shorting of some printed circuit boards could result in a possible interruption of therapy or cause the pump to fail the Power-On Self Test.