Conmed System 5000 Electrosurgical unit, REF 60-8005-SYS, 60-8015-SYS, 60-8018-SYS, 60-8005-001, 60-8005-003, Conmed Cor
FDA device recall Z-1508-06 · posted 2006-09-19 · Terminated
Recall details
- Recalling firm
- Conmed Electrosurgery
- Reason for recall
- Wrong size capacitor installed in electrosurgical generator could malfunction, causing muscle stimulation or delay in therapy.
- Action taken
- Domestic customers were notified by letter on 09/01/2006 and international accounts were notified by letter on 09/07/2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 44 units (domestic), 40 units (International)
- Distribution
- Worldwide, including USA, Australia, Canada, France, Japan, Korea, New Zealand, Saudi Arabia, UK.
- Date initiated
- 2006-09-05
- Date posted
- 2006-09-19
- Date terminated
- 2006-10-26
- Location
- Centennial, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CONMED SYSTEM 5000 ESU (K020186) | Conmedcorp | 2002-04-12 |