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Recall Observatory FDA recall evidence

Device product

VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Accelerator 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-1308-2016

March 07, 2016

Class II

Product summary

Firm
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
Event
Event 73436
Status
Terminated
Classification
Class II
Quantity
25 Worldwide, US: 4 units
Official record key
device-enforcement:Z-1308-2016

Official wording

Reason: In rare cases the VERO/MHI-TM2000 Operator Console could set an incorrect Gantry angle for the first beam of an IMRT treatment if certain specific conditions are met. If Gantry angle for the first beam of IMRT is incorrectly set and if nobody is aware of it, an erroneous treatment would be given to the patient.

Code information: Software version 3.5.8, 3.5.2 and lower; Serial Numbers: 201902, 203901, 203919, 203924

Distribution pattern: Nationwide Distribution including New York, Texas, Florida, and Ohio

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    In rare cases the VERO/MHI-TM2000 Operator Console could set an incorrect Gantry angle for the first beam of an IMRT treatment if certain specific conditions are met. If Gantry angle for the first beam of IMRT is incorrectly set and if nobody is aware of it, an erroneous treatment would be given to the patient.