Company:Physio-Control, Inc.
Date of Enforcement Report 3/15/2017
Class l
PRODUCT
The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR and the use of the LIFEPAK 1000 defibrillator.
Recall Number Z-1257-2017
REASON
The firm has received complaints that the LIFEPAK 1000 Defibrillator is unexpectedly powering off during device usage.
RECALLING FIRM/MANUFACTURER
Physio-Control, Inc. REdmond, WA on 1/13/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
total 133,330 units (50,046 units in the US)
DISTRIBUTION
Nationwide and Internationally
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