FDA recall Z-2689-2020

Philips North America, LLC · Class II · device

Product

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

Reason for recall

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.

Distribution

Worldwide distribution - US Nationwide distribution.

Key facts

Status: Ongoing
Initiation date: 2020-06-25
Report date: 2020-07-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2689-2020