Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
FDA Recall Z-0028-2007 · Posted 2006-10-12
Recalling FirmLumenis Inc.
Recall StatusTerminated
Product CodeGEX
Date Initiated2006-08-29
Date Terminated2007-01-22
Product Quantity10,815
Reason for Recall
Device lacks the black indicator markings on the metal tip and there is the potential for fiber degradation (detachment of the metal cap, and the fiber lasing straight) during use.
Firm Action
On 8/26/06, the firm initiated the recall and its notification was via letters and phone calls requesting return of affected product.
Root Cause
Other
Distribution Pattern
Worldwide, including USA, Japan, Europe, Hong Kong, Russia and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.