FDA Medical Device Recalls (openFDA)
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK: VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.
- Recall number
- Z-0821-2015
- 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.
- Status
- Terminated
- Initiated
- 2014-12-02
- Posted
- 2014-12-17
- Terminated
- 2017-06-26
- Reason
- 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
- 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: Franz.Gum@brainlab.com. 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
- Domestic: 4 units
- Distribution
- US Distribution to the states of NY, FL, TX and OH.
- Lot, serial or model codes
- Serial Numbers: 201902, 203901, 203919, and 203924 (US only)
- 510(k) numbers
- ["K072047","K122450"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 3006942329
- Firm city
- HIROSHIMA
- Firm state
- 4-CHOME KAN-ON-SHIN-MACHI
- Firm country
- Japan
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28