Z-0545-06

Lumenis brand Atlas, Corium, Elite, Elite Ultra 532nm Laser Systems; Manufactured before November 4, 2003...

Name: Z-0545-06 Lumenis brand Atlas, Corium, Elite, Elite Ultra 532nm Laser Systems; Manufactured before November 4, 2003...
Creator: Lumenis Inc.
Published: 2006-02-01
License: https://open.fda.gov/license/

Lumenis Ltd / initiated 2006-02-01 / Terminated

FDA source

Lumenis Inc. began a recall of Lumenis brand Atlas, Corium, Elite, Elite Ultra 532nm Laser Systems; Manufactured before November 4, 2003; Manufactured by Lumenis, Inc., 3959 West 1820 South... on 2006-02-01. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0545-06
Status: Terminated
Initiated: 2006-02-01
Posted: 2006-03-02
Terminated: 2006-12-21
Recalling firm: Lumenis Ltd
Product: 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
Product code: GEX Powered Laser Surgical Instrument
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.
FDA root cause: Other
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.
Quantity in commerce: Approx. 1436 units
Distribution: 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.
Product codes and lots: All codes manufactured prior to November 4, 2003.

Product code GEX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)