Terminated

ConMed System 2450 Electrosurgical Generator, REF 60-2450-220, 220 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.

FDA Recall Z-1364-2011 · Posted 2011-02-17

Recalling FirmConMed Electrosurgery

Recall StatusTerminated

Product CodeGEI

Date Initiated2010-12-27

Date Terminated2011-08-01

Product Quantity467 units

Reason for Recall

Electrosurgical generator may allow possibility of electrical shock and/or burns to user or patient.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, Uruguay, Venezuela, Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052009CONMED SYSTEM MODEL 2450 ELECTROSURGICAL GENERATORConmed Corporation · 2005-09-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.