Philips IntelliVue TcG10 Monitor Recalled for Missing Contraindication Warning
Philips is recalling 86 IntelliVue TcG10 monitors because the instructions for use are missing a warning against using the device on patients under gas anesthesia.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a missing safety warning (documentation issue) rather than a physical defect, and no injuries or illnesses are reported in the source text.
Plain-English summary
Philips Medical Systems, Inc. is recalling 86 units of the IntelliVue TcG10 Transcutaneous Gas Measurement Module. This device is used to measure transcutaneous oxygen and carbon dioxide partial pressure in neonates, pediatrics, and adults.
The recall was initiated because the Instructions for Use (IFU) for the device are missing a specific contraindication. The missing warning states that the device is not to be used on patients under gas anesthesia. The affected units were distributed in the states of California, Hawaii, Illinois, Massachusetts, Michigan, Missouri, Montana, North Carolina, Ohio, and Pennsylvania.
Healthcare facilities should check their inventory for the specific serial numbers listed in the recall notice. If a unit is affected, it should be removed from service and returned to Philips for the necessary corrective action.
The recalled product
- Product
- Philips IntelliVue TcG10; Monitor, carbon-dioxide, cutaneous. The IntelliVue TcG10 is a device for the measurement of the transcutaneous O2 and CO2 partial pressure in neonates, pediatrics and adults.
- Manufacturer
- Philips Medical Systems, Inc.
- Category
- Medical Device — Patient Monitor
- Affected units
- 86
Distribution
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