FDA Recall
Terminated
Coherent brand Quattro Diode Laser Systems; A Quattro FAP System; Model Numbers/Serial Numbers: TFAP0004P--TFAP00048
Recall: Z-0357-04
·
Initiated November 17, 2003
Recall
- Recall Number
- Z-0357-04
- Event Number
- 28434
- Firm
- Coherent Inc Laser Group
- FEI Number
- 2916213
- Product Code
- --
- Status
- Terminated
- Root Cause
- Other
- Initiated
- November 17, 2003
- Posted
- July 20, 2004
- Terminated
- July 8, 2005
- Address
- 5100 Patrick Henry Dr, Santa Clara, CA, 95054-1112
Description
Coherent brand Quattro Diode Laser Systems; A Quattro FAP System; Model Numbers/Serial Numbers: TFAP0004P--TFAP00048
Reason
Software problem that may cause the instrument to remain on and emitting laser radiation after the interlock has been activated.
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.
Distribution
52 units were released for distribution to consignees in U.S. nationally.
Quantity
52 units