Company: Hitachi Ltd., Medical System Operations Group
Date of Enforcement Report 5/9/2018
Class II:

PRODUCT
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. Recall Number: Z-1585-2018

REASON
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.

RECALLING FIRM/MANUFACTURER
Hitachi Ltd., Medical System Operations Group, Kashiwa, Japan 12/8/2017. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1

DISTRIBUTION
New York