Coherent brand DUO Diode Laser Systems. A Non-medical, class IV industrial materials processing machine.
FDA device recall Z-0360-04 · posted 2004-11-30 · Terminated
Recall details
- Recalling firm
- Coherent, Inc.
- Reason for recall
- Software problem that may cause unintended emission of laser radiation.
- Action taken
- On 3/30/04, the firm initiated the recall and their notification was via letters informing its customers of the corrective action.
- Root cause
- Other
- Status
- Terminated
- Product code
- L--22
- Quantity affected
- 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.
- Date initiated
- 2004-03-30
- Date posted
- 2004-11-30
- Date terminated
- 2005-08-04
- Location
- Santa Clara, CA
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