FDA Device

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

Hazard

Software anomaly recorded incorrect filter in patient database and this may lead to patient skin burns.

What You Should Do

Remedy

On 4/8/05, the firm initiated the recall and its notification was via letters informing its customers of the corrective action.

Products

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
Brand
Lumenis Inc.
UPC
Software versions lower than 2.02 All serial numbers; All codes

Units Affected

142 units