FDA-Device2020-07-29Class II

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

Philips North America, LLC
Hazard

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.

Sold states
Worldwide distribution - US Nationwide distribution.
Affected count
3075
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.12.00, System Codes 453564477391, 453564477401, 866173

Official notice

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

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