VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Accelerator MHI-TM2000 Linear Accelerator Syst

FDA device recall Z-1308-2016 · posted 2016-03-31 · Terminated

Recall details

Recalling firm

MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK

Reason for recall

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.

Action taken

A Field Safety Notice dated March 2, 2016, was sent to all affected customers via e-mail on March 7, 2016. The Field Safety Notice informed users of the problem and provided a safe workaround until corrected software is available. The correction will be free of charge and a Customer Service Representative will contact all affected customers to schedule its installation. Customers with questions were advised to contact their Customer Service Representative.

Root cause

Software design

Status

Terminated

Product code

IYE

Quantity affected

25 Worldwide, US: 4 units

Distribution

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

Date initiated

2016-03-07

Date posted

2016-03-31

Date terminated

2017-04-20

Location

HIROSHIMA, 4-CHOME KAN-ON-SHIN-MACHI, Japan

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