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Terminated

Coherent brand Quattro Diode Laser Systems; A Quattro FAP System; Model Numbers/Serial Numbers: TFAP0004P--TFAP00048

FDA Recall Z-0357-04 · Posted 2004-07-20

Recalling FirmCoherent Inc Laser Group
Recall StatusTerminated
Date Initiated2003-11-17
Date Terminated2005-07-08
Product Quantity52 units

Reason for Recall

Software problem that may cause the instrument to remain on and emitting laser radiation after the interlock has been activated.

Firm 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.

Root Cause

Other

Distribution Pattern

52 units were released for distribution to consignees in U.S. nationally.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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