FDA Recall
Terminated
Coherent brand DUO Diode Laser Systems. A Non-medical, class IV industrial materials processing machine.
Recall: Z-0360-04
·
Initiated March 30, 2004
Recall
- Recall Number
- Z-0360-04
- Event Number
- 30397
- Firm
- Coherent, Inc.
- FEI Number
- 2916213
- Product Code
- L--22
- Status
- Terminated
- Root Cause
- Other
- Initiated
- March 30, 2004
- Posted
- November 30, 2004
- Terminated
- August 4, 2005
- Address
- 5100 Patrick Henry Dr, Santa Clara, CA, 95054-1112
Description
Coherent brand DUO Diode Laser Systems. A Non-medical, class IV industrial materials processing machine.
Reason
Software problem that may cause unintended emission of laser radiation.
Action
On 3/30/04, the firm initiated the recall and their notification was via letters informing its customers of the corrective action.
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.
Quantity
75 units