28
Apr
2004

Inc Class II Gyrus Medical

0

Company: Gyrus Medical, Inc
Date of Enforcement Report: 4/28/04
Class: II

PRODUCT
Gyrus PlasmaKinetic Super Pulse Generator is a micro-computer based radio frequency generator with electrical and software components made of biocompatible materials for medical applications. Recall # Z-0841-04.

REASON
The generator may malfunction when used in close proximity to a monopolar generator.

CODE
Model 744000.

RECALLING FIRM/MANUFACTURER
Gyrus Medical, Inc., Maple Grove, MN, by letter on December 5, 2003. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
14.

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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