Reported Jan 28, 2015 · Terminated

Philips IntelliVue TcG10; Monitor, carbon-dioxide, cutaneous. The IntelliVue TcG10 is a device for the measurement of…

Philips Medical Systems, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips Medical Systems, Inc. · 3000 Minuteman Rd · Andover, MA · 01810-1032

Is this the product you have?

  • 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.
Lot codes and dates
  • Serial Numbers

    86 of 86 codes

    • 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
Amount recalled
86

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 29, 2015 · Data as of Sep 19, 6:04 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.