—#209939

Product

IntelliVue G7m Anesthesia Gas Module, Product Number 866173

FDA product code: DSI — Detector And Alarm, Arrhythmia
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K151681
Affected lot / code info: UDI-DI: 00884838051492; Serial Numbers: DE43800129 through DE43812627

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

An IMPORTANT PRODUCT NOTICE dated 1/18/23 was sent to customers. The actions planned by Philips to correct the problem A Philips representative will reach out to you to arrange a replacement of the sample gas pump. Affected products and how to identify them Affected product is the 866173 lntelliVue G7m Anesthesia Gas Module. Both the product number and the serial number on the G7m product is contained on the back of the product, preceded by "REF" and "SN", respectively. If you need any further information or support concerning this issue, please contact your local Philips representative.

Recalling firm

Firm: Philips North America
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2296

Distribution

Distribution pattern: US Nationwide. Global Distribution.

Timeline

Recall initiated: 2023-01-18
Posted by FDA: 2024-10-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209939. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.