Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended f

FDA device recall Z-2770-2015 · posted 2015-09-16 · Terminated

Recall details

Recalling firm

Lumenis

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

GCJ

Quantity affected

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 R

Date initiated

2015-07-30

Date posted

2015-09-16

Date terminated

2018-05-25

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