Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0007-2025Class II

IntelliVue G7m Anesthesia Gas Module, Product Number 866173

Philips North America LLC / initiated 2023-01-18 / Open, Classified

Philips North America began a recall of IntelliVue G7m Anesthesia Gas Module, Product Number 866173 on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-0007-2025
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Philips North America LLC
Product
IntelliVue G7m Anesthesia Gas Module, Product Number 866173
Product code
DSI Detector And Alarm, Arrhythmia
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.
FDA root cause
Under Investigation by firm
Action
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.
Quantity in commerce
8,449 devices
Distribution
US Nationwide. Global Distribution.
Product codes and lots
UDI-DI: 00884838051492; Serial Numbers: DE43800129 through DE43812627

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0007-2025
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0007-2025Class IIOngoingVoluntary: Firm initiated