Philips IntelliVue G7m Anesthesia Gas Module Firmware Recall
Philips is recalling 3,075 IntelliVue G7m Anesthesia Gas Modules due to a firmware issue that may interrupt gas measurement and display.
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: The recall involves a medical device used in anesthesia where a failure to measure gas levels poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Philips North America, LLC is recalling 3,075 units of the IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.12.00. The affected devices have System Codes 453564477391, 453564477401, and 866173.
The recall is due to a firmware issue that may cause an interruption of gas measurement. When this occurs, the device ceases the measurement and display of gas levels and generates one or more technical or INOP alarms.
The affected units were distributed worldwide and nationwide in the United States. Healthcare facilities should check their inventory for the specific serial numbers listed in the recall notice and contact Philips for instructions on how to resolve the issue.
The recalled product
- Product
- IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.12.00, System Codes 453564477391, 453564477401, 866173
- Manufacturer
- Philips North America, LLC
- Affected units
- 3,075
Distribution
Distributed nationwide across the United States.
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