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