FDA Medical Device Recalls (openFDA)
Conmed Electrosurgery: Conmed System 5000 Electrosurgical unit, REF 60-8005-SYS, 60-8015-SYS, 60-8018-SYS, 60-8005-001, 60-8005-003, Conmed Corporation.
- Recall number
- Z-1508-06
- Recalling firm
- Conmed Electrosurgery
- Product
- Conmed System 5000 Electrosurgical unit, REF 60-8005-SYS, 60-8015-SYS, 60-8018-SYS, 60-8005-001, 60-8005-003, Conmed Corporation.
- Status
- Terminated
- Initiated
- 2006-09-05
- Posted
- 2006-09-19
- Terminated
- 2006-10-26
- Reason
- Wrong size capacitor installed in electrosurgical generator could malfunction, causing muscle stimulation or delay in therapy.
- Root cause
- Other
- Action
- Domestic customers were notified by letter on 09/01/2006 and international accounts were notified by letter on 09/07/2006.
- Quantity
- 44 units (domestic), 40 units (International)
- Distribution
- Worldwide, including USA, Australia, Canada, France, Japan, Korea, New Zealand, Saudi Arabia, UK.
- Lot, serial or model codes
- Serial Numbers: 06GGP 004, 06GGP 005, 06GGP 009, 06GGP 011, 06GGP 012, 06GGP 024, 06GGP 027 thru 030, 06GGP 057 thru 059, 06GGP 090 thru 092, 06GGP 131 thru 140, 06GGP 141 thru 144 ,,, 06FGP 022, 06FGP 023, 06FGP 029 thru 046, 06FGP 048 thru 056, 06FGP 062 thru 071, 06FGP 073 thru 079, 06FGP 090, 06FGP 106, 06FGP 107, 06FGP 110 thru 112 .
- 510(k) numbers
- ["K020186"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 3004491689
- Firm city
- Centennial
- Firm state
- CO
- 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