Philips IntelliVue G7m Anesthesia Gas Module Pump Failure
Philips IntelliVue G7m Anesthesia Gas Modules may have a faulty sample gas pump that could stop working, interrupting gas measurement. Affected devices have serial numbers DE43800129 through DE43812627.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for potential failure of anesthesia gas measurement during patient procedures. No illnesses or injuries have been reported. Per the severity rubric, this constitutes a risk-of-harm product where injury has not yet been reported, warranting a High (3) severity score.
Plain-English summary
Philips North America is recalling approximately 8,449 IntelliVue G7m Anesthesia Gas Modules (Product Number 866173) due to a potential failure in the sample gas pump. The pump may stop working prematurely when friction or abrasion occurs, producing an INOP (inoperable) alarm and interrupting the measurement of anesthesia gases.
The affected devices are distributed nationwide in the United States and globally. They can be identified by serial numbers ranging from DE43800129 through DE43812627.
A failure of the gas measurement function during anesthesia administration could affect patient care and monitoring during surgical procedures.
Healthcare facilities using these modules should verify they do not have affected devices by checking serial numbers and follow Philips North America guidance on replacement or repair options.
The recalled product
- Product
- IntelliVue G7m Anesthesia Gas Module, Product Number 866173
- Manufacturer
- Philips North America
- Affected units
- 8,449
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 00884838051492
- Serial Numbers: DE43800129 through DE43812627
Distribution
Distributed nationwide across the United States.
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