Z-0841-04

Gyrus PlasmaKinetic Super Pulse Generator is a micro-computer based radio frequency generator with electrical...

Name: Z-0841-04 Gyrus PlasmaKinetic Super Pulse Generator is a micro-computer based radio frequency generator with electrical...
Creator: Gyrus Medical, Inc
Published: 2003-12-05
License: https://open.fda.gov/license/

Gyrus ACMI, Inc. / initiated 2003-12-05 / Terminated

FDA source

Gyrus Medical, Inc began a recall of Gyrus PlasmaKinetic Super Pulse Generator is a micro-computer based radio frequency generator with electrical and software components made of biocompatible... on 2003-12-05. The reason FDA records is "The generator may malfunction when used in close proximity to a monopolar generator". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0841-04
Status: Terminated
Initiated: 2003-12-05
Posted: 2004-07-20
Terminated: 2006-12-28
Recalling firm: Gyrus ACMI, Inc.
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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: The generator may malfunction when used in close proximity to a monopolar generator.
FDA root cause: Other
Action: 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.
Quantity in commerce: 14
Distribution: Nationwide throughout the United States.
Product codes and lots: Model 744000

Product code GEI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)