15
Feb
2017

LIFEPAK 15 Monitor/Defibrillator Cl II

0

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

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About the author

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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