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Recall Observatory FDA recall evidence

Device 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.

Z-1585-2018

December 08, 2017

Class II

Product summary

Firm
Hitachi Ltd., Medical System Operations Group
Event
Event 79439
Status
Terminated
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-1585-2018

Official wording

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.

Code information: Serial Number: 203919

Distribution pattern: US Distribution in the state of NY.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software anomaly