Z-0540-04

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

Name: Z-0540-04 Coherent brand DUO Diode Laser Systems. A Non-medical, class IV industrial materials processing machine. The...
Creator: Coherent, Inc.
Published: 2004-01-19
License: https://open.fda.gov/license/

Coherent, Inc. / initiated 2004-01-19 / Terminated / root cause: software

FDA source

Coherent, Inc. began a recall of Coherent brand DUO Diode Laser Systems. A Non-medical, class IV industrial materials processing machine. The following Model---Serial Numbers (S/N) are... on 2004-01-19. The reason FDA records is "Software problem that may cause unintended emission of laser radiation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0540-04
Status: Terminated
Initiated: 2004-01-19
Posted: 2004-11-16
Terminated: 2005-08-04
Recalling firm: Coherent, Inc.
Product: 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.
Product code: L22
Reason for recall: Software problem that may cause unintended emission of laser radiation.
Root cause tag: software
FDA root cause: Other
Action: On 1/19/04, the firm initiated the recall and their notification was via letters informing its customers of the corrective action.
Quantity in commerce: 93 units
Distribution: 10 US customers and 6 foreign customers in Canada, Germany, Japan received this product, with 1 wholesale dealer in Amersham Health, Durham, NC.
Product codes and lots: 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.

Product code L22

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)