Home / Recalls / Hitachi Ltd., Medical System Operations Group / Z-1585-2018

Z-1585-2018 Class II Terminated

Recalled by Hitachi Ltd., Medical System Operations Group — Kashiwa, N/A

Recall Details

Product Type: Devices
Report Date: May 9, 2018
Initiation Date: December 8, 2017
Termination Date: April 11, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1

Product Description

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.

Reason for Recall

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.

Distribution Pattern

US Distribution in the state of NY.

Code Information

Serial Number: 203919