19
Jan
2011

One Cat. Life Pulse High Frequency Ventilato Cl ll

0

Company: Bunnell Inc.
Date of Enforcement Report 1/19/2011
Class ll:

PRODUCT
1) One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203A, Rx Only. Recall # Z-0901-2011;
2) One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203, Rx Only. Recall # Z-0902-2011

REASON
Product software coding error may compromise patient safety.

RECALLING FIRM/MANUFACTURER
Bunnell, Inc., Salt Lake City, UT, by letter starting October 22, 2010. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
660units

DISTRIBUTION
Nationwide, Australia, Canada, Czech Republic, Korea, Malaysia, Trinidad & Tobago, and Uruguay

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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Instructor: Dr Peter Rech, 2nd instructor (optional)

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