Home / Recalls / Medical Devices
Lumenis recalls Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intende
Recalled September 23, 2015 · FDA recall Z-2770-2015 · Lumenis
Hazard
There is a probability the hand piece may operate inconsistently and unpredictably during the morcellation procedure resulting in damage to non-target tissue. · FDA Class II
Units
54 devices with 108 hand pieces
Sold at
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.
Description
There is a probability the hand piece may operate inconsistently and unpredictably during the morcellation procedure resulting in damage to non-target tissue.
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.
Manufacturer(s)
Lumenis
Made in
Israel
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →