FDA-Device2015-05-20Class II
GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).
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
Sold states
Worldwide Distribution - US including CO, MI, WI and Internationally to NETHERLANDS, FINLAND, and BELGIUM.
Affected count
110 (83 units US, 27 units OUS)
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1606-2015Don't want to check this manually?
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