Feb

2017

LIFEPAK 12 Defibrillator/Monitor Cl II

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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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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LIFEPAK 12 Defibrillator/Monitor Cl II

Amy Sellers

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