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U.S. Department of Health and Human Services

Class 2 Device Recall Lumenis VersaCut Tissue Morcellator

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  Class 2 Device Recall Lumenis VersaCut Tissue Morcellator see related information
Date Initiated by Firm July 30, 2015
Date Posted September 16, 2015
Recall Status1 Terminated 3 on May 25, 2018
Recall Number Z-2770-2015
Recall Event ID 71851
510(K)Number K133272  
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
Product Lumenis VersaCut+ Tissue Morcellator GA-0007500

The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.
Code Information GA-0007500 (VersaCut + System with Inverted H/P) and GA-0007600 (VersaCut + System with Regular H/P). Only the hand pieces for the system (SA4769200 inverted HP, SA4768700 regular HP) are affected by this recall.
Recalling Firm/
Manufacturer		 Lumenis
13 Hayetzira St.,Yokneam Ind. Park
Yokneam Israel
For Additional Information Contact Brett Godfrey
801-656-2663
Manufacturer Reason
for Recall		 There is a probability the hand piece may operate inconsistently and unpredictably during the morcellation procedure resulting in damage to non-target tissue.
FDA Determined
Cause 2		 Device Design
Action Lumenis sent an Urgent Medical Device Recall letter on August 7, 2015, to all consignees. Consignees were instructed to destroy the operator manual, and return the affected device to Lumenis along with the completed Recall Verification form. Consignees with questions were instructed to call 801-656-2663.
Quantity in Commerce 54 devices with 108 hand pieces
Distribution Worldwide Distribution - US including CA, PA, MA, FL, and NY, and Internationally to Italy, Germany, Australia, China, Great Britian, United Kingdom, Taiwan, France, Peru, Mexico, Turkey, Spain, and Russia.
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 = GCJ and Original Applicant = LUMENIS LTD.
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