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Terminated

Lumenis brand Atlas, Corium, Elite, Elite Ultra 532nm Laser Systems; Manufactured before November 4, 2003; Manufactured by Lumenis, Inc., 3959 West 1820 South, Salt Lake City, Utah 84104

FDA Recall Z-0545-06 · Posted 2006-03-02

Recalling FirmLumenis Inc.
Recall StatusTerminated
Product CodeGEX
Date Initiated2006-02-01
Date Terminated2006-12-21
Product QuantityApprox. 1436 units

Reason for Recall

The BP/Notch filter may be out of specification and may cause injury to the patient's eye due to high power (energy) delivered by the Laser System during medical procedures.

Firm Action

On 7/26/04 and 2/1/06 the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned for correction.

Root Cause

Other

Distribution Pattern

Nationwide. The product was released for distribution to 1431 consignees worldwide. International consignees include: Australia, Canada, India, Netherlands, Argentina, France, Malaysia, Italy, Brazil, Mexico, China, Colombia, Thailand, Holland, Japan, and Venezuela. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K990179BURNFREE 1/8 OZ. STERILE PAIN RELIEVING GEL, MODEL SDNortrade Medical, Inc. · 1999-08-13K913569COMPAC A, ELITE A, ELITE A PLUS, SURGICA AHgm Medical Laser Systems, Inc. · 1991-10-17

Official Source

View FDA Recall →

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

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