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Recall Observatory FDA recall evidence

Device product

IntelliVue G7m Anesthesia Gas Module, Product Number 866173

Z-0007-2025

January 18, 2023

Class II

Product summary

Firm
Philips North America
Event
Event 95301
Status
Ongoing
Classification
Class II
Quantity
8,449 devices
Official record key
device-enforcement:Z-0007-2025

Official wording

Reason: 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.

Code information: UDI-DI: 00884838051492; Serial Numbers: DE43800129 through DE43812627

Distribution pattern: US Nationwide. Global Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.