Lumenis brand Atlas, Corium, Elite, Elite Ultra 532nm Laser Systems; Manufactured before November 4, 2003; Manufactured
FDA device recall Z-0545-06 · posted 2006-03-02 · Terminated
Recall details
- Recalling firm
- Lumenis Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 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,
- Date initiated
- 2006-02-01
- Date posted
- 2006-03-02
- Date terminated
- 2006-12-21
- Location
- Santa Clara, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BURNFREE 1/8 OZ. STERILE PAIN RELIEVING GEL, MODEL SD (K990179) | Nortrade Medical, Inc. | 1999-08-13 |
| COMPAC A, ELITE A, ELITE A PLUS, SURGICA A (K913569) | Hgm Medical Laser Systems, Inc. | 1991-10-17 |