CLASS II Device recall · Reported 28 Jan 2015 · FDA Enforcement Report

Philips IntelliVue TcG10 recalled by Philips Medical Systems

Philips Medical Systems is recalling Philips IntelliVue TcG10, distributed in 10 states. The recall was initiated on 19 Nov 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial 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

Quantity recalled86

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0997-2015
FDA event ID: 69742
Recalling firm: Philips Medical Systems, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 19 Nov 2014
FDA classified: 16 Jan 2015
Reported: 28 Jan 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

19 Nov 2014	Recall initiated by company
16 Jan 2015	Classified by FDA	+58 days
28 Jan 2015	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

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.

Where it was distributed

Distributed in the states of CA, HI, IL, MA, MI, MO, MT, NC, OH, and PA.

California Hawaii Illinois Massachusetts Michigan Missouri Montana North Carolina Ohio Pennsylvania

Questions about this recall

Is Philips IntelliVue TcG10 recalled?

Yes. Philips Medical Systems recalled Philips IntelliVue TcG10 on 19 Nov 2014. The recall is Class II and its status is Terminated. Recall number Z-0997-2015.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

Distributed in the states of CA, HI, IL, MA, MI, MO, MT, NC, OH, and PA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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