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
CH03800507CH03800508CH03800509CH03800510CH03800559CH03800560CH03800573CH03800574CH03800575CH03800576CH03800577CH03800578CH03800579CH03800580CH03800633CH03800634CH03800637CH03800638CH03800642CH03800676CH03800678CH03800685CH03800687CH03800688CH03800690CH03800692CH03800693CH03800694CH03800695CH03800696CH03800697UK21001105UK21001111UK21001123UK21001134UK21001144UK21001154UK21001162UK21001164UK21001166UK21001185UK21001188UK21001189UK21001194UK21001212UK21001213UK21001215UK21001216UK21001230UK21001237UK21001245UK21001247UK21001257UK21001287UK21001294UK21001298UK21001299UK21001313UK21001318UK21001319
- Serial Numbers
- 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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