Cl II Zoll 731 Series Ventilators

Company:ZOLL Medical Corporation
Date of Enforcement Report 3/7/2018
Class lI:


731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for use in the management of infant through adult patients weighing ;:: 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation.
Recall Number Z-0812-2018

A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user inadvertently changing device settings.

ZOLL Medical Corporation, Chelmsford, MA on 6/30/2017. Voluntary: Firm Initiated recall is ongoing.


Outside US


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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