Hitachi Ltd., Medical System Operations Group: Medical Device Recall in 2018 - (Recall #: Z-1585-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 8, 2017

Date Posted: May 9, 2018

Recall Number: Z-1585-2018

Event ID: 79439

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.

Status: Terminated

Product Quantity: 1

Code Information:

Serial Number: 203919

Distribution Pattern:

US Distribution in the state of NY.

Voluntary or Mandated:

Voluntary: Firm initiated