Philips Medical Systems, Inc. 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. Recall
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Philips Medical Systems, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Serial Numbers: CH03800507 CH03800508 CH03800509 CH03800510 CH03800559 CH03800560 CH03800573 CH03800574 CH03800575 CH03800576 CH03800577 CH03800578 CH03800579 CH03800580 CH03800633 CH03800634 CH03800637 CH03800638 CH03800642 CH03800676 CH03800678 CH03800685 CH03800687 CH03800688 CH03800690 CH03800692 CH03800693 CH03800694 CH03800695 CH03800696 CH03800697 UK21001105 UK21001111 UK21001123 UK21001134 UK21001144 UK21001154 UK21001162 UK21001164 UK21001166 UK21001185 UK21001188 UK21001189 UK21001194 UK21001212 UK21001213 UK21001215 UK21001216 UK21001230 UK21001237 UK21001245 UK21001247 UK21001257 UK21001287 UK21001294 UK21001298 UK21001299 UK21001313 UK21001318 UK21001319 UK21001332 UK21001348 UK21001363 UK21001366 UK21001371 UK21001384 UK21001386 UK21001399 UK21001401 UK21001405 UK21001425 UK21001436 UK21001437 UK21001461 UK21001468 UK21001469 UK21001479 UK21001480 UK21001556 UK21001557 UK21001577 UK21001579 UK21001662 UK21001770 UK21001841 UK21001979
Philips Medical Systems, Inc. is recalling Philips IntelliVue TcG10; Monitor, carbon-dioxide, cutaneous. The IntelliVue TcG10 is a device fo due to Philips has discovered that the Instructions for Use (IFU) for the IntelliVue TcG10 Transcutaneous Gas Measurement Module is missing the contraindicat. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Philips has discovered that the Instructions for Use (IFU) for the IntelliVue TcG10 Transcutaneous Gas Measurement Module is missing the contraindication that the device is not to be used on patients under gas anesthesia.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, HI, IL, IN, MA, MI, MO, MT, NC, OH, PA
Page updated: Jan 12, 2026