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Terminated

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

FDA Recall Z-0360-04 · Posted 2004-11-30

Recalling FirmCoherent, Inc.
Recall StatusTerminated
Product CodeL--22
Date Initiated2004-03-30
Date Terminated2005-08-04
Product Quantity75 units

Reason for Recall

Software problem that may cause unintended emission of laser radiation.

Firm Action

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

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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