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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Lot Codes / Batch Numbers
Software versions lower than 2.02 All serial numbers, All codes
Products Sold
Software versions lower than 2.02 All serial numbers; All codes
Lumenis Inc. is recalling Lumenis brand Lumenis One System with Multi-Spot Nd:YAG, LightSheer and Universal IPL; Manufactured due to Software anomaly recorded incorrect filter in patient database and this may lead to patient skin burns.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software anomaly recorded incorrect filter in patient database and this may lead to patient skin burns.
Recommended Action
Per FDA guidance
On 4/8/05, the firm initiated the recall and its notification was via letters informing its customers of the corrective action.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026