Recall Z-0529-06 ยท GEX Powered Laser Surgical Instrument
Lumenis Inc.
Lumenis brand Lumenis One System with Multi-Spot Nd:YAG, LightSheer and Universal IPL; Manufactured by Lumenis, Ltd, 13 Hayetzira Street, Yokneam Industrial Park, Yokneam, Israel 20692
| Date | Feb 16, 2006 (initiated Apr 8, 2005) |
| Status | Terminated |
| Reason | Software anomaly recorded incorrect filter in patient database and this may lead to patient skin burns. |
| Root cause | Other |
| Action | On 4/8/05, the firm initiated the recall and its notification was via letters informing its customers of the corrective action. |
| Quantity | 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 distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030342 | LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS Lumenis, Ltd., Jul 17, 2003 |