Company: Lumenis, Inc.
Date of Enforcement Report:2/22/2006
Class:lI
PRODUCT
Lumenis brand Lumenis One System with Multi-Spot Nd: YAG, LightSheer and Universal IPL, Recall # Z-0529-06
REASON
Software anomaly recorded incorrect filter in patient database and this may lead to patient skin burns.
CODE
Software versions lower than 2.02. All serial numbers; All codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lumenis, Inc., Santa Clara, CA, by letters on April 8, 2005.
Manufacturer: Lumenis, Ltd., Yokneam, Israel. Firm initiated recall is complete
VOLUME OF PRODUCT IN COMMERCE
142 units
DISTRIBUTION
Nationwide and New Zealand
