Cl II GE Healthcare Carescape Patient Data Module

Company: GE Healthcare
Date of Enforcement Report: 10/15/2014
Class lI:

PRODUCT

GE Healthcare Carescape Patient Data Module
Recall Number Z-0060-2015

REASON
GE Healthcare has recently become aware of a potential safety issue to the ECG calculations following a disconnect/reconnect cycle with the Patient Data Module, when used with the Carescape Bx50 monitors. If the PDM is quickly disconnected and reconnected (a less than 10 second cycle) from a Carescape Bx50 monitor following a Patient Discharge or during active monitoring, the ECG waveform and its associated waveform parameters could be analyzed incorrectly.

RECALLING FIRM/MANUFACTURER
GE Healthcare, Waukesha, WI on 9/19/2014 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
68,452 (39,505 units US, 24,711 units OUS, 4,236 units unidentified/unknown)

DISTRIBUTION
Nationwide and Internationally

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