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

Recall date

July 30, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2770-2015

FDA classification

Class II

Brand / firm

Lumenis

Sold / distributed

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.

Why it was recalled

There is a probability the hand piece may operate inconsistently and unpredictably during the morcellation procedure resulting in damage to non-target tissue.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.