Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 24, 2014
VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.
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…
Mitsubishi Heavy Industries, LTD., Hiroshima Machinery Work recalled VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Softw… - a moderate-severity action.
VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Softw… was recalled by Mitsubishi Heavy Industries, LTD., Hiroshima Machinery Work in December 24, 2014. Reason: Software Anomaly. The VERO MHI-TM2000 Operator Console may provide Patient Positioning System (ExacTrac) with…. Check the official notice for the remedy. Verify recall #Z-0821-2015 with the FDA Devices before acting.
The recall
Mitsubishi Heavy Industries, LTD., Hiroshima Machinery Work issued this moderate-severity FDA Devices recall-Software Anomaly. The VERO MHI-TM2000 Operator Console may provide Patient Positioning System (ExacTrac) with….
- Moderate
- severity level
- Class II
- classification
- December 24, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0821-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0821-2015) was formally reported on December 24, 2014, with the manufacturer initiating the action on December 2, 2014. 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 Domestic: 4 units.
The documented reason for this recall is: 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, Exac… Distribution data in the federal record shows the product reached: US Distribution to the states of NY, FL, TX and OH.. 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 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
Domestic: 4 units
Related Recalls
6
3 from same agency
Product description
VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0821-2015 |
| Date reported | December 24, 2014 |
| Date initiated | December 2, 2014 |
| Recalling firm | Mitsubishi Heavy Industries, LTD., Hiroshima Machinery Work |
| Firm location | HIROSHIMA, N/A |
| Affected scope | Domestic: 4 units |
| Distribution | US Distribution to the states of NY, FL, TX and OH. |
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-0821-2015) 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? ▼
VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.. Recalled by Mitsubishi Heavy Industries, LTD., Hiroshima Machinery Work. Units affected: Domestic: 4 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 24, 2014. Severity: Moderate. Recall number: Z-0821-2015.
Where was the recalled product distributed? ▼
Distribution: US Distribution to the states of NY, FL, TX and OH..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0821-2015) 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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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 24, 2014. 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 July 2026.