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.
FDA Recall Z-0540-04 · Posted 2004-11-16
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Recalling FirmCoherent, Inc.
Recall StatusTerminated
Product CodeL22
Date Initiated2004-01-19
Date Terminated2005-08-04
Product Quantity93 units
Reason for Recall
Software problem that may cause unintended emission of laser radiation.
Firm Action
On 1/19/04, the firm initiated the recall and their notification was via letters informing its customers of the corrective action.
Root Cause
Other
Distribution Pattern
10 US customers and 6 foreign customers in Canada, Germany, Japan received this product, with 1 wholesale dealer in Amersham Health, Durham, NC.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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