Z-0821-2015Class II

VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1...

Name: Z-0821-2015 VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1...
Creator: Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery Work
Published: 2014-12-02
License: https://open.fda.gov/license/

Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery Work / initiated 2014-12-02 / Terminated / root cause: software

FDA source

MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK began a recall of VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0 on 2014-12-02. FDA classified it as Class II and gives the reason as "Software Anomaly. The VERO MHI-TM2000 Operator Console may provide Patient Positioning System (ExacTrac) with Image Angle Information Used for the 1st Port Image, for a subsequent port image fusion. As the result...". 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-0821-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-02
Posted: 2014-12-17
Terminated: 2017-06-26
Recalling firm: Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery Work
Product: VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Software Anomaly. The VERO MHI-TM2000 Operator Console may provide Patient Positioning System (ExacTrac) with Image Angle Information Used for the 1st Port Image, for a subsequent port image fusion. As the result, ExacTrac may display a Digitally Reconstructed Radiograph (DRR) image taken from the angle for the 1st port image fusion, rather than the one taken from the angle for the intended port
Root cause tag: software
FDA root cause: Software design
Action: Mitsubishi sent a Field Safety Notice dated November 14, 2014, that was e-mailed to US end users on December 2, 2014, which provided actions to be taken by the end users. If users need any further information or support concerning this issue, they may contact MHI's Customer Service Representative, Brainlab AG in Germany, contact person: Franz Gum, Tel: +49-89-99-1568-0, Fax: +49-89-99-1568-33, E-mail: [email protected]. If any other abnormality is detected, stop operation and contact MHI's Customer Service representative immediately. --- An Updated Field Safety Notice (dated December 4, 2014,) was sent to end users to correct some terms used in the initial notification.
Quantity in commerce: Domestic: 4 units
Distribution: US Distribution to the states of NY, FL, TX and OH.
Product codes and lots: Serial Numbers: 201902, 203901, 203919, and 203924 (US only)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0821-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0821-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17

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)