Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Lumenis

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Lumenis see related information
Date Initiated by Firm April 08, 2005
Date Posted February 16, 2006
Recall Status1 Terminated 3 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
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 2		 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 and Original Applicant = LUMENIS, LTD.
-
-