The Recall Desk

Manufacturer

MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK

6 recalls in our database name MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK as the manufacturing or recalling firm.

What the numbers show

Total
6
Critical
0
Severe
0
Most recent
2016-04-06

Of the 6 recalls from MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–6 of 6

  • HighFDA (Devices)·Z-1308-2016·2016-04-06

    Mitsubishi VERO MHI-TM2000 Linear Accelerator Recall for Gantry Angle Error

    Mitsubishi Heavy Industries is recalling VERO MHI-TM2000 Linear Accelerators because the operator console may set an incorrect gantry angle for the first beam of an IMRT treatment.

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1244-2016·2016-03-30

    MHI-TM2000 Linear Accelerator Software Recall for Treatment Status Error

    Mitsubishi Heavy Industries is recalling MHI-TM2000 Linear Accelerator Systems due to a software anomaly that may incorrectly change a patient's treatment status to 'Untreated'.

    Product
    MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1574-2015·2015-05-13

    MHI-TM2000 Linear Accelerator System Software Recall for Communication Errors

    Mitsubishi Heavy Industries is recalling 11 MHI-TM2000 Linear Accelerator Systems due to a software defect that allows radiation delivery despite communication errors and prevents saving treatment records.

    Product
    MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0821-2015·2014-12-24

    Mitsubishi VERO Linear Accelerator Software Recall for Image Display Error

    Mitsubishi Heavy Industries is recalling four VERO Linear Accelerator systems in the US due to a software anomaly that may display incorrect image angles for patient positioning.

    Product
    VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2653-2014·2014-09-24

    Mitsubishi Vero Linear Accelerator Software Recall for Treatment Status Errors

    Mitsubishi Heavy Industries is recalling three Vero Linear Accelerator systems in the US due to a software defect that may incorrectly mark completed radiation treatments as untreated.

    Product
    VERO Linear Accelerator System, Model Number MHI-TM2000; 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.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1931-2013·2013-08-14

    Mitsubishi VERO Linear Accelerator Software Recall for Data Storage Error

    Mitsubishi Heavy Industries is recalling VERO Linear Accelerator Systems due to a software anomaly that may save treatment records to the wrong location.

    Product
    MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and cond
    Category
    Medical Device
    Distribution
    Distributed nationwide