ConMed System 2450 Electrosurgical Generator, REF 60-2450-100, 100 V, ConMed Electrosurgery, Centennial, CO. A general-p
FDA device recall Z-1362-2011 · posted 2011-02-17 · Terminated
Recall details
- Recalling firm
- ConMed Electrosurgery
- Reason for recall
- Electrosurgical generator may allow possibility of electrical shock and/or burns to user or patient.
- Action taken
- ConMed Electrosurgery sent an Urgent Device Recall letter dted December 27, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify anyone who may have received the affected product.. They were to review their inventory and return a Business Reply Form via fax to 303-699-9854 and to contact ConMed Electrosurgery Technical Services at 800-552-0138 to schedule a time to have their equipment upgraded.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 119 units
- Distribution
- Worldwide Distribution, including USA (nationwide) and the countries of Australia, Belgium, Bolivia, Canada, Chile, China, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Fin
- Date initiated
- 2010-12-27
- Date posted
- 2011-02-17
- Date terminated
- 2011-08-01
- Location
- Centennial, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CONMED SYSTEM MODEL 2450 ELECTROSURGICAL GENERATOR (K052009) | Conmed Corporation | 2005-09-28 |