Oct

2019

Recall – Telemetry System Server error disables patient monitor alarms

Company: GE Healthcare, LLC
Date of Enforcement Report: 10/23/2019
Class II

PRODUCT

ApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry System and ApexPro FH Telemetry System – Product Usage: These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered.

Recall Number: Z-0175-2020

REASON

May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Information Center monitor for ECG arrhythmias, ECG LEADS FAIL or Pulse Oximetry (SpO2) under certain conditions.

RECALLING FIRM/MANUFACTURER

GE Healthcare, LLC on 08/30/2019. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

21,132 (17,218 US; 3,914 OUS) devices total

DISTRIBUTION

Nationwide and International

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