Conmed System 2500 Electrosurgical Unit, REF 60-8011-SYS, Conmed Corporation
FDA device recall Z-1507-06 · 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
- 19 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
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CONMED SYSTEM 2000 ELECTROSURGICAL GENERATOR, REF: 60-8002; CONMED ESU CART, REF: 60-6120 (K020135) | Conmedcorp | 2002-04-12 |