Company: Philips North America, LLC
Date of Enforcement Report: 7/29/2020
Class II

PRODUCT

IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.12.00, System Codes 453564477391, 453564477401, 866173

Recall Number: Z-2689-2020

REASON

The device may experience an interruption of gas measurement due to a firmware issue, ceasing measurement and display of gas levels and generating one or more technical or INOP alarms.

RECALLING FIRM/MANUFACTURER

Philips North America, LLC on 6/25/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

3075

DISTRIBUTION

U.S. Nationwide and International