FDA Medical Device Recalls (openFDA)
Gyrus Medical, Inc: 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 number
- Z-0841-04
- Recalling firm
- Gyrus Medical, 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.
- Status
- Terminated
- Initiated
- 2003-12-05
- Posted
- 2004-07-20
- Terminated
- 2006-12-28
- Reason
- The generator may malfunction when used in close proximity to a monopolar generator.
- 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
- 14
- Distribution
- Nationwide throughout the United States.
- Lot, serial or model codes
- Model 744000
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 3011050570
- Firm city
- Maple Grove
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28