Hitachi Ltd., Medical System Operations Group recalls MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation ther…

Recall date

December 8, 2017

Source

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

Recall number

Z-1585-2018

FDA classification

Class II

Brand / firm

Hitachi Ltd., Medical System Operations Group

Sold / distributed

US Distribution in the state of NY.

Why it was recalled

Due to a system controller software anomaly, the patient positioning deviation correction may not be applied and may result in the wrong part of the patient being irradiated.

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

What was recalled

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