14
Jul
2004

Inc Class II Respironics Novametrix

0

Company: Respironics Novametrix, Inc
Date of Enforcement Report: 7/14/04
Class: II

PRODUCT
Model 509M Pulse Oximetry Interface Module Software. Recall # Z-1049-04.

REASON
Audio alarm may fail to sound when Sp02 limits drop below the set limits.

CODE
Software versions 2.0 or 2.5.

RECALLING FIRM/MANUFACTURER
Respironics Novametrix, Inc., Wallingford, CT, by letter dated September 3, 2002 and February 24, 2004. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
901 units.

DISTRIBUTION
Nationwide.

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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