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U.S. Department of Health and Human Services

Class 2 Device Recall FemTouch delivery system

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  Class 2 Device Recall FemTouch delivery system see related information
Date Initiated by Firm September 25, 2016
Date Posted October 23, 2016
Recall Status1 Terminated 3 on April 11, 2017
Recall Number Z-0301-2017
Recall Event ID 75384
510(K)Number K100415  
Product Classification Powered laser surgical instrument - Product Code GEX
Product FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590)

Provide fractional treatments in gynecology.
Code Information All serial numbers
Recalling Firm/
Manufacturer		 Lumenis Limited
13 Hayetzira St.,Yokneam Ind. Park
Yokneam Israel
Manufacturer Reason
for Recall		 The cleaning instructions provided in FemTouch Operator's Manual might be ineffective for a fully assembled device and may lead to a potential for cross-contamination.
FDA Determined
Cause 2		 Software Manufacturing/Software Deployment
Action On 9/25/16 consignees were notified via an Urgent - Field Safety Corrective Action letter with a FemTouch disassembly tool kit as well as FemTouch disassembly instructions. The instructions describe the simple disassembly process to be performed as part of the Pre-cleaning phase and the process for reassembling the device prior to re-use. It is recommended that customers clean and sterilize all of their handpieces according to the pre-cleaning disassembly process before each use. Consignees were asked to complete and return a verification form. Questions about the FSCA, should be directed to the Lumenis field correction administrator, Rafi Barel at Rafi.Barel@lumenis.com.
Quantity in Commerce 69 units
Distribution Worldwide Distribution -- USA, Italy, Russian Fed., Australia, United Arab Emirates, Spain, United Kingdom, India, Kuwait, and Belarus.
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
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