Company: GE Healthcare, LLC
Date of Enforcement Report: 8/12/2020
Class II
PRODUCT
CARESCAPE ONE, Physiological Patient Monitor – Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility.
Recall Number: Z-2750-2020
REASON
CARESCAPE ONE may not provide visual and audible alarms for Ventricular Fibrillation (V Fib), if V Fib occurs at the time CARESCAPE ONE is docked to a CARESCAPE B450/B650/B850 host monitor.
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC on 6/22/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
8,414 units
DISTRIBUTION
U.S. Nationwide and International