Conmed System 2500 Electrosurgical Unit, REF 60-8011-SYS, Conmed Corporation
FDA Recall Z-1507-06 · Posted 2006-09-19
Recalling FirmConmed Electrosurgery
Recall StatusTerminated
Product CodeGEI
Date Initiated2006-09-05
Date Terminated2006-10-26
Product Quantity19 units (International)
Reason for Recall
Wrong size capacitor installed in electrosurgical generator could malfunction, causing muscle stimulation or delay in therapy.
Firm Action
Domestic customers were notified by letter on 09/01/2006 and international accounts were notified by letter on 09/07/2006.
Root Cause
Other
Distribution Pattern
Worldwide, including USA, Australia, Canada, France, Japan, Korea, New Zealand, Saudi Arabia, UK.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.