IntelliVue G7m Anesthesia Gas Module, Product Number 866173
FDA device recall Z-0007-2025 · posted 2024-10-01 · Open, Classified
Recall details
- Recalling firm
- Philips North America
- 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.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- DSI
- Quantity affected
- 8,449 devices
- Distribution
- US Nationwide. Global Distribution.
- Date initiated
- 2023-01-18
- Date posted
- 2024-10-01
- Location
- Cambridge, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IntelliVue Patient Monitor (K151681) | Philips Medizin Systeme Boeblingen GmbH | 2015-07-17 |