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GE Healthcare recalls GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).
Recalled May 20, 2015 · FDA recall Z-1606-2015 · GE Healthcare
Hazard
The heart rate could be calculated from pacer pulses without indication that pacemaker detection is OFF in some combinations of Bx50 monitors, a PDM, and CIC/CSCS. Then the monitor does not show the Pacer Off message and there may not be an alarm for asystole. Undetected asystole could result in irreversible changes in the patient¿s condition and delayed or missed life sustaining patient treatment · FDA Class II
Units
110 (83 units US, 27 units OUS)
Sold at
Worldwide Distribution - US including CO, MI, WI and Internationally to NETHERLANDS, FINLAND, and BELGIUM.
Description
The heart rate could be calculated from pacer pulses without indication that pacemaker detection is OFF in some combinations of Bx50 monitors, a PDM, and CIC/CSCS. Then the monitor does not show the Pacer Off message and there may not be an alarm for asystole. Undetected asystole could result in irreversible changes in the patient¿s condition and delayed or missed life sustaining patient treatment
Product
GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).
Manufacturer(s)
GE Healthcare
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →