Recall Register

MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK: FDA recalls

FDA enforcement reports name MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK as the recalling firm in 6 events. The events have 6 product records. The recalls started from 2013 to 2016. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

6 events, newest first.

FDA enforcement events of MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
InitiatedProduct (first record)TypeClassRecordsStatus
7 Mar 2016VERO 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.DeviceClass II1Terminated
15 Dec 2015MHI-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.DeviceClass II1Terminated
17 Apr 2015MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)DeviceClass II1Terminated
2 Dec 2014VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.DeviceClass II1Terminated
5 Jul 2014VERO 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.DeviceClass II1Terminated
21 Jun 2013MHI-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 conditions anywhere in the body where radiation…DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK: events for each product type
TypeEvents
Device6
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK: events in each class
ClassEvents
Class II6
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
0

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK, by the year that the recall started. The largest year is 2014, with 2 events.

Official channels

Cite this page

Recall Register. MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK: FDA recalls. https://recallregister.com/firm/mitsubishi-heavy-industries-ltd-hiroshima-machinery-work/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
N/A

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK have?
Class II: 6 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK?
FDA event 73436, which the firm started on 7 Mar 2016. The first product in the record is: 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.
How many FDA recalls of MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK have the status Ongoing?
No event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.