Z-0007-2025 Class II Ongoing
FDA device recall Z-0007-2025 was initiated by Philips North America on January 18, 2023 and is designated Class II. 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 wo… The recall status is ongoing. Affected quantity: 8,449 devices.
Recall Details
- Product Type
- Devices
- Report Date
- October 9, 2024
- Initiation Date
- January 18, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,449 devices
Product Description
IntelliVue G7m Anesthesia Gas Module, Product Number 866173
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.
Distribution Pattern
US Nationwide. Global Distribution.
Code Information
UDI-DI: 00884838051492; Serial Numbers: DE43800129 through DE43812627