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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0007-2025 | Class II | Ongoing | Voluntary: Firm initiated |
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