Product Wiki · Recalls · U.S. FDA — Device Enforcement

GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50). — recall Z-1606-2015

U.S. FDA — Device Enforcement · United States · 2015-05-04 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1606-2015
Date of alert
2015-05-04
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
GE Healthcare
Product category
device
Product type
Devices
Reported risk: 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
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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