Company: Physio-Control, Inc.
Date of Enforcement Report 2/15/2017
Class lI:
PRODUCT
LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. Intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions.
Recall Number Z-1144-2017
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
2584 units total (1501 units in the US; 1034 units international; and 49 units owned by Physio). 50 modules total
DISTRIBUTION
Nationwide and Internationally
___________________________________
