FDA recall Z-0007-2025

Philips North America · Class II · device

Product

IntelliVue G7m Anesthesia Gas Module, Product Number 866173

Reason for recall

The 866173 lntelliVue G7m Anesthesia Gas Modules could have a component issue that may trigger an interruption of the gas measurement. This issue concerns the G7m's sample gas pump which could stop working, producing a technical, INOP (inoperable) alarm. The pump may fail prematurely when there is friction caused by an abrasion. This recall is for an IMPORTANT PRODUCT NOTICE dated 1/18/23.

Distribution

US Nationwide. Global Distribution.

Key facts

Status
Ongoing
Initiation date
2023-01-18
Report date
2024-10-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0007-2025