FDA Medical Device Recalls (openFDA)
Lumenis Inc.: 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
- Recall number
- Z-0545-06
- Recalling firm
- Lumenis Inc.
- 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
- Status
- Terminated
- Initiated
- 2006-02-01
- Posted
- 2006-03-02
- Terminated
- 2006-12-21
- Reason
- 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.
- 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
- 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.
- Lot, serial or model codes
- All codes manufactured prior to November 4, 2003.
- 510(k) numbers
- ["K913569","K990179"]
- PMA numbers
- not on file
- Product code
- GEX
- Firm FEI
- 2914019
- Firm city
- Santa Clara
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28