Recall – Patient monitor may not produce alarms when docked

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

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15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.