FDA Device

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.

Hazard

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

What You Should Do

Remedy

On December 05, 2003, the firm sent recall notices to their affected customers by Certified Mail. The customers were notified that the firm would call them to arrange for pick up and correction of the device.

Products

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.
Brand
Gyrus Medical, Inc
UPC
Model 744000

Units Affected

14