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

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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