Recall record at a glance
| Official record | Z-0007-2025 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Philips North America |
| Report date | Oct 9, 2024 |
| Recall initiation date | Jan 18, 2023 |
| Quantity | 8,449 devices |
| Location | Cambridge, MA, United States |
Official product description
IntelliVue G7m Anesthesia Gas Module, Product Number 866173
Why the product was 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.
Distribution information
US Nationwide. Global Distribution.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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