GE Healthcare recalls GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).

Recall date

May 4, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1606-2015

FDA classification

Class II

Brand / firm

GE Healthcare

Sold / distributed

Worldwide Distribution - US including CO, MI, WI and Internationally to NETHERLANDS, FINLAND, and BELGIUM.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).