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
|