Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1507-06

Conmed System 2500 Electrosurgical Unit, REF 60-8011-SYS, Conmed Corporation

ConMed Corporation / initiated 2006-09-05 / Terminated

Conmed Electrosurgery began a recall of Conmed System 2500 Electrosurgical Unit, REF 60-8011-SYS, Conmed Corporation on . The reason FDA records is "Wrong size capacitor installed in electrosurgical generator could malfunction, causing muscle stimulation or delay in therapy". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1507-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
ConMed Corporation
Product
Conmed System 2500 Electrosurgical Unit, REF 60-8011-SYS, Conmed Corporation
Product code
GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall
Wrong size capacitor installed in electrosurgical generator could malfunction, causing muscle stimulation or delay in therapy.
FDA root cause
Other
Action
Domestic customers were notified by letter on 09/01/2006 and international accounts were notified by letter on 09/07/2006.
Quantity in commerce
19 units (International)
Distribution
Worldwide, including USA, Australia, Canada, France, Japan, Korea, New Zealand, Saudi Arabia, UK.
Product codes and lots
Serial numbers: 06GGN 001 thru 009, 06FGN 001 thru 010.