FDA Device

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

Hazard

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.

What You Should Do

Remedy

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.

Products

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
Brand
Lumenis Inc.
UPC
All codes manufactured prior to November 4, 2003.

Units Affected

Approx. 1436 units