Lumenis brand Lumenis One System with Multi-Spot Nd:YAG, LightSheer and Universal IPL; Manufactured by Lumenis, Ltd, 13
FDA device recall Z-0529-06 · posted 2006-02-16 · Terminated
Recall details
- Recalling firm
- Lumenis Inc.
- Reason for recall
- Software anomaly recorded incorrect filter in patient database and this may lead to patient skin burns.
- Action taken
- On 4/8/05, the firm initiated the recall and its notification was via letters informing its customers of the corrective action.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 142 units
- Distribution
- The product was released for distribution to 124 consignees nationwide. One international consignee includes: New Zealand. There were no shipments to U.S. Government facilities or foreign or Canadian
- Date initiated
- 2005-04-08
- Date posted
- 2006-02-16
- Date terminated
- 2006-12-28
- 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 |
|---|---|---|
| LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS (K030342) | Lumenis, Ltd. | 2003-07-17 |