Z-1308-2016Class II

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

Name: Z-1308-2016 VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Accelerator MHI-TM2000 Linear...
Creator: Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery Work
Published: 2016-03-07
License: https://open.fda.gov/license/

Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery Work / initiated 2016-03-07 / Terminated / root cause: software

FDA source

MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK began a recall of VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Accelerator MHI-TM2000 Linear Accelerator System is intended for radiation therapy of... on 2016-03-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1308-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-07
Posted: 2016-03-31
Terminated: 2017-04-20
Recalling firm: Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery Work
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.
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 25 Worldwide, US: 4 units
Distribution: Nationwide Distribution including New York, Texas, Florida, and Ohio
Product codes and lots: Software version 3.5.8, 3.5.2 and lower; Serial Numbers: 201902, 203901, 203919, 203924

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1308-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1308-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-31

Product code IYE

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)