Z-0357-04

Coherent brand Quattro Diode Laser Systems; A Quattro FAP System; Model Numbers/Serial Numbers...

Name: Z-0357-04 Coherent brand Quattro Diode Laser Systems; A Quattro FAP System; Model Numbers/Serial Numbers...
Creator: Coherent Inc Laser Group
Published: 2003-11-17
License: https://open.fda.gov/license/

Coherent, Inc. / initiated 2003-11-17 / Terminated / root cause: software

FDA source

Coherent Inc Laser Group began a recall of Coherent brand Quattro Diode Laser Systems; A Quattro FAP System; Model Numbers/Serial Numbers: TFAP0004P--TFAP00048 on 2003-11-17. The reason FDA records is "Software problem that may cause the instrument to remain on and emitting laser radiation after the interlock has been activated". 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-0357-04
Status: Terminated
Initiated: 2003-11-17
Posted: 2004-07-20
Terminated: 2005-07-08
Recalling firm: Coherent, Inc.
Product: Coherent brand Quattro Diode Laser Systems; A Quattro FAP System; Model Numbers/Serial Numbers: TFAP0004P--TFAP00048
Product code: --
Reason for recall: Software problem that may cause the instrument to remain on and emitting laser radiation after the interlock has been activated.
Root cause tag: software
FDA 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 in commerce: 52 units
Distribution: 52 units were released for distribution to consignees in U.S. nationally.
Product codes and lots: Serial Numbers/Model Numbers: TFAP0004P--TFAP00048

Product code --

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)