Philips Medical Systems, Inc. recalls Philips IntelliVue TcG10; Monitor, carbon-dioxide, cutaneous. The IntelliVue TcG10 is a device for the measurement of t…
- Recall date
- November 19, 2014
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0997-2015
- FDA classification
- Class II
- Brand / firm
- Philips Medical Systems, Inc.
- Sold / distributed
- Distributed in the states of CA, HI, IL, MA, MI, MO, MT, NC, OH, and PA.
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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