Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0360-04

Coherent brand DUO Diode Laser Systems. A Non-medical, class IV industrial materials processing machine

Coherent, Inc. / initiated 2004-03-30 / Terminated / root cause: software

Coherent, Inc. began a recall of Coherent brand DUO Diode Laser Systems. A Non-medical, class IV industrial materials processing machine on . The reason FDA records is "Software problem that may cause unintended emission of laser radiation". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-0360-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Coherent, Inc.
Product
Coherent brand DUO Diode Laser Systems. A Non-medical, class IV industrial materials processing machine.
Product code
L--22
Reason for recall
Software problem that may cause unintended emission of laser radiation.
Root cause tag
software
FDA root cause
Other
Action
On 3/30/04, the firm initiated the recall and their notification was via letters informing its customers of the corrective action.
Quantity in commerce
75 units
Distribution
The firm has distributed 75 units to 10 US and 6 foreign consignees locatedd in Canada, Germany, and Japan. There is one wholesale dealer client, Amersham Health, located in Durham, NC.
Product codes and lots
All serial numbers are affected by this recall action. Serial numbers range from 1003 to 1092.