Recall Z-0007-2025 ยท DSI Detector And Alarm, Arrhythmia
Philips North America
IntelliVue G7m Anesthesia Gas Module, Product Number 866173
| Date | Oct 1, 2024 (initiated Jan 18, 2023) |
| Status | Open, Classified |
| 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. |
| 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 | 8,449 devices |
| Distribution | US Nationwide. Global Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151681 | IntelliVue Patient Monitor Philips Medizin Systeme Boeblingen GmbH, Jul 17, 2015 |