CLASS II ONGOING Device recall · Reported 9 Oct 2024 · FDA Enforcement Report
IntelliVue G7m Anesthesia Gas Module, Product Number recalled
Philips North America is recalling IntelliVue G7m Anesthesia Gas Module, Product Number 866173, distributed nationwide in the US. The recall was initiated on 18 Jan 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0007-2025
- FDA event ID
- 95301
- Recalling firm
- Philips North America, Cambridge, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Jan 2023
- FDA classified
- 1 Oct 2024
- Reported
- 9 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 18 Jan 2023 | Recall initiated by company | |
| 1 Oct 2024 | Classified by FDA | +622 days |
| 9 Oct 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
IntelliVue G7m Anesthesia Gas Module, Product Number 866173
Where it was distributed
US Nationwide. Global Distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI-DI: 00884838051492; Serial Numbers: DE43800129 through DE43812627
Where was it sold?
US Nationwide. Global Distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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