FDA-Device2015-01-28Class II
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.
Philips Medical Systems, Inc.
Hazard
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.
Sold states
Distributed in the states of CA, HI, IL, MA, MI, MO, MT, NC, OH, and PA.
Affected count
86
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0997-2015Don't want to check this manually?
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