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...Read More
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