Jul

2017

Draeger Infinity Acute Care System Cl II

Company:Draegar Medical Systems, Inc.
Date of Enforcement Report 7/26/2017
Class lI:

PRODUCT

Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722.
Recall Number Z-2734-2017

REASON
Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio or visual alarms on the Cockpit and Central Station..

RECALLING FIRM/MANUFACTURER
Draegar Medical Systems, Inc., Andover, MA on 6/6/2017. Voluntary: Firm Initiated recall is ongling.

VOLUME OF PRODUCT IN COMMERCE
37 US and 682 OUS

DISTRIBUTION
Nationwide and Internationally

___________________________________

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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Draeger Infinity Acute Care System Cl II

Amy Sellers

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