09
Apr
2014

Zoll Defibrillator/Pacemaker/Monitors Cl II

0

Company ZOLL Medical Corporation.
Date of Enforcement Report:4/9/2014
Class lI:

PRODUCT

Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated external defibrillator.
Recall Number Z-1311-2014

REASON
Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used

RECALLING FIRM/MANUFACTURER
ZOLL Medical Corporation, Chelmsford, MA on.3/52014. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
3,169 unit

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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