FDA Recall
Terminated
Coherent brand DUO Diode Laser Systems. A Non-medical, class IV industrial materials processing machine. The following Model---Serial Numbers (S/N) are affected: P/N 1024403---S/Ns 10026 Through 10088; P.V. -4240/4475---S/Ns 2, 7, 3053, and 10002 through 10024; and P. V. -4458 S/Ns 10019, 10019, 10020, 10043, and 10052.
Recall: Z-0540-04
·
Initiated January 19, 2004
Recall
- Recall Number
- Z-0540-04
- Event Number
- 30415
- Firm
- Coherent, Inc.
- FEI Number
- 2916213
- Product Code
- L22
- Status
- Terminated
- Root Cause
- Other
- Initiated
- January 19, 2004
- Posted
- November 16, 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. The following Model---Serial Numbers (S/N) are affected: P/N 1024403---S/Ns 10026 Through 10088; P.V. -4240/4475---S/Ns 2, 7, 3053, and 10002 through 10024; and P. V. -4458 S/Ns 10019, 10019, 10020, 10043, and 10052.
Reason
Software problem that may cause unintended emission of laser radiation.
Action
On 1/19/04, the firm initiated the recall and their notification was via letters informing its customers of the corrective action.
Distribution
10 US customers and 6 foreign customers in Canada, Germany, Japan received this product, with 1 wholesale dealer in Amersham Health, Durham, NC.
Quantity
93 units