Recall Z-1363-2011 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ConMed Electrosurgery
ConMed System 2450 Electrosurgical Generator, REF 60-2450-120, 120 V, ConMed Electrosurgery, Centennial, CO. A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of high (HF) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site.
| Date | Feb 17, 2011 (initiated Dec 27, 2010) |
| Status | Terminated |
| Reason | Electrosurgical generator may allow possibility of electrical shock and/or burns to user or patient. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 1266 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, Finland, France, Honduras, Hong Kong, Hungary, India, Iraq, Israel, Italy, Jamaica, Japan, Jordan, Leba |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052009 | CONMED SYSTEM MODEL 2450 ELECTROSURGICAL GENERATOR Conmed Corporation, Sep 28, 2005 |