FDA Medical Device Recalls (openFDA)
Coherent Inc Laser Group: Coherent brand Quattro Diode Laser Systems; A Quattro FAP System; Model Numbers/Serial Numbers: TFAP0004P--TFAP00048
- Recall number
- Z-0357-04
- Recalling firm
- Coherent Inc Laser Group
- Product
- Coherent brand Quattro Diode Laser Systems; A Quattro FAP System; Model Numbers/Serial Numbers: TFAP0004P--TFAP00048
- Status
- Terminated
- Initiated
- 2003-11-17
- Posted
- 2004-07-20
- Terminated
- 2005-07-08
- Reason
- Software problem that may cause the instrument to remain on and emitting laser radiation after the interlock has been activated.
- Root cause
- Other
- Action
- On 11/7/03, all consignees were notified via Certified Mail and on-site visit by the firm''s sales representative, informing them of the affected devices and providing instructions on the recall.
- Quantity
- 52 units
- Distribution
- 52 units were released for distribution to consignees in U.S. nationally.
- Lot, serial or model codes
- Serial Numbers/Model Numbers: TFAP0004P--TFAP00048
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- --
- 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