Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 14, 2013
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 conditions anywhere in the body where radiation treatment is indicated
Software anomaly: Mitsubishi Heavy Industries, Ltd. became aware of a potential safety issue associated with the VERO (TM) Linear Accelerator System. The VERO (TM) may save treat…
Mitsubishi Heavy Industries, LTD., Hiroshima Machinery Work recalled MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Pro… — a moderate-severity action.
MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Pro… was recalled by Mitsubishi Heavy Industries, LTD., Hiroshima Machinery Work in August 14, 2013. Reason: Software anomaly: Mitsubishi Heavy Industries, Ltd. became aware of a potential safety issue associated with …. Check the official notice for the remedy. Verify recall #Z-1931-2013 with the FDA Devices before acting.
The recall
Mitsubishi Heavy Industries, LTD., Hiroshima Machinery Work issued this moderate-severity FDA Devices recall — Software anomaly: Mitsubishi Heavy Industries, Ltd. became aware of a potential safety issue associated with ….
- Moderate
- severity level
- Class II
- classification
- August 14, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1931-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1931-2013) was formally reported on August 14, 2013, with the manufacturer initiating the action on June 21, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Mitsubishi Heavy Industries, LTD., Hiroshima Machinery Work is listed as the recalling firm, operating out of HIROSHIMA, N/A. Federal records list the affected scope as 14 (2 in US).
The documented reason for this recall is: Software anomaly: Mitsubishi Heavy Industries, Ltd. became aware of a potential safety issue associated with the VERO (TM) Linear Accelerator System. The VERO (TM) may save treatment delivery record into wrong location… Distribution data in the federal record shows the product reached: Worldwide distribution: US (nationwide) including states of TX and FL; and countries of: Belgium, Italy, Japan and Korea.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Affected scope
14 (2 in US)
Related Recalls
6
6 from same agency
Product description
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 conditions anywhere in the body where radiation treatment is indicated
Reason for recall
Software anomaly: Mitsubishi Heavy Industries, Ltd. became aware of a potential safety issue associated with the VERO (TM) Linear Accelerator System. The VERO (TM) may save treatment delivery record into wrong location under certain conditions.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1931-2013 |
| Date reported | August 14, 2013 |
| Date initiated | June 21, 2013 |
| Recalling firm | Mitsubishi Heavy Industries, LTD., Hiroshima Machinery Work |
| Firm location | HIROSHIMA, N/A |
| Affected scope | 14 (2 in US) |
| Distribution | Worldwide distribution: US (nationwide) including states of TX and FL; and countries of: Belgium, Italy, Japan and Korea. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1931-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting — recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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 conditions anywhere in the body where radiation treatment is indicated. Recalled by Mitsubishi Heavy Industries, LTD., Hiroshima Machinery Work. Units affected: 14 (2 in US).
Why was this product recalled? ▼
Software anomaly: Mitsubishi Heavy Industries, Ltd. became aware of a potential safety issue associated with the VERO (TM) Linear Accelerator System. The VERO (TM) may save treatment delivery record into wrong location under certain conditions.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 14, 2013. Severity: Moderate. Recall number: Z-1931-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution: US (nationwide) including states of TX and FL; and countries of: Belgium, Italy, Japan and Korea..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1931-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported August 14, 2013.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.