Company: Physio-Control, Inc.
Date of Enforcement Report 2/15/2017
Class lI:
PRODUCT
LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is used in various areas of the hospital such as critical areas (emergency departments, critical care, operating room, etc.) and general duty floors (e.g. medical/surgical). The device is also used for in and out of hospital transport (air and ground ambulance, in hospital transport, etc.) l
Recall Number Z-1143-2017
REASON
The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation.
RECALLING FIRM/MANUFACTURER
Physio-Control, Inc., Redmond, WA on 1/16/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
7 units in the US and 13 modules worldwide
DISTRIBUTION
Nationwide and Internationally
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