Class 2 Device Recall Lumenis

• Date Initiated by Firm: April 08, 2005
• Date Posted: February 16, 2006
• Recall Status: Terminated on December 28, 2006
• Recall Number: Z-0529-06
• Recall Event ID: 34556
• 510(K)Number: K030342
• Product Classification: Powered Laser Surgical Instrument - Product Code GEX
• 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
• Code Information: Software versions lower than 2.02 All serial numbers; All codes
• FEI Number: 2914019
• Recalling Firm/ Manufacturer: Lumenis Inc.; 2400 Condensa St; Santa Clara CA 95051-0901
• Manufacturer Reason for Recall: Software anomaly recorded incorrect filter in patient database and this may lead to patient skin burns.
• FDA Determined 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 in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GEX