FDA Medical Device Recalls (openFDA)
Coherent, Inc.: 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 number
- Z-0540-04
- 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.
- Status
- Terminated
- Initiated
- 2004-01-19
- Posted
- 2004-11-16
- Terminated
- 2005-08-04
- Reason
- Software problem that may cause unintended emission of laser radiation.
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- L22
- Firm FEI
- 2916213
- Firm city
- Santa Clara
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28