Recall Z-0545-06 ยท GEX Powered Laser Surgical Instrument
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
| Date | Mar 2, 2006 (initiated Feb 1, 2006) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |