MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is i...
FDA Recall #Z-1585-2018 — Class II — December 8, 2017
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.
Recalling Firm
Hitachi Ltd., Medical System Operations Group — Kashiwa, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1
Distribution
US Distribution in the state of NY.
Code Information
Serial Number: 203919
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated