Recall Z-0007-2025
Philips North America · initiated January 18, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
IntelliVue G7m Anesthesia Gas Module, Product Number 866173
Codes / lots: UDI-DI: 00884838051492; Serial Numbers: DE43800129 through DE43812627
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-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-0007-2025
- Initiated
- January 18, 2023
- Posted by FDA
- October 1, 2024
- Product code
- DSI – Detector And Alarm, Arrhythmia
- Quantity
- 8,449 devices
- Distribution
- US Nationwide. Global Distribution.
- Recalling firm
- Philips North America, Cambridge, MA