Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1508-06

Conmed System 5000 Electrosurgical unit, REF 60-8005-SYS, 60-8015-SYS, 60-8018-SYS, 60-8005-001, 60-8005-003...

ConMed Corporation / initiated 2006-09-05 / Terminated

Conmed Electrosurgery began a recall of Conmed System 5000 Electrosurgical unit, REF 60-8005-SYS, 60-8015-SYS, 60-8018-SYS, 60-8005-001, 60-8005-003, 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-1508-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
ConMed Corporation
Product
Conmed System 5000 Electrosurgical unit, REF 60-8005-SYS, 60-8015-SYS, 60-8018-SYS, 60-8005-001, 60-8005-003, 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
44 units (domestic), 40 units (International)
Distribution
Worldwide, including USA, Australia, Canada, France, Japan, Korea, New Zealand, Saudi Arabia, UK.
Product codes and lots
Serial Numbers: 06GGP 004, 06GGP 005, 06GGP 009, 06GGP 011, 06GGP 012, 06GGP 024, 06GGP 027 thru 030, 06GGP 057 thru 059, 06GGP 090 thru 092, 06GGP 131 thru 140, 06GGP 141 thru 144 ,,, 06FGP 022, 06FGP 023, 06FGP 029 thru 046, 06FGP 048 thru 056, 06FGP 062 thru 071, 06FGP 073 thru 079, 06FGP 090, 06FGP 106, 06FGP 107, 06FGP 110 thru 112 .