16
Jul
2003

Inc. Class II Draeger Medical

0

Company: Draeger Medical, Inc.
Date of Enforcement Report: 7/16/03
Class: II

PRODUCT
Evita 4 Continuous Ventilator. Catalog numbers 4116640 and 8412980. Recall # Z-0954-03.

REASON
Software problems – ventilation mode changes without user input, settings change without corresponding display change, false auto-set alarm.

CODE
Software version 4.00 or 4.10.

RECALLING FIRM/MANUFACTURER
Draeger Medical, Inc., Telford, PA, by letters dated May 7, 2003. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
806 units.

DISTRIBUTION
Nationwide, and Canada.

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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