MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK recalls VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Accelerator MHI-TM2000 Linear Accelerator Sys…

Recall date

March 7, 2016

Source

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

Recall number

Z-1308-2016

FDA classification

Class II

Brand / firm

MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK

Sold / distributed

Nationwide Distribution including New York, Texas, Florida, and Ohio

Why it was recalled

In rare cases the VERO/MHI-TM2000 Operator Console could set an incorrect Gantry angle for the first beam of an IMRT treatment if certain specific conditions are met. If Gantry angle for the first beam of IMRT is incorrectly set and if nobody is aware of it, an erroneous treatment would be given to the patient.

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

What was recalled

VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Accelerator MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.