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.
