Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 28, 2018
Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1, MT6XSM1.4.0-2, MT6SXM1.4.0-3, MT6XSM1.5.0-2, MT6XSM1.6.0-1, MT6XSM1.7.2, MT6XSM1.7.2-1, MT6XSM1.7.2-3, MT6XSM1.7.3, MT6XSM1.7.3-1, MT6XSM1.7.3-3. The Protura Software is intended to interface between record and verify systems, linear accelerator (Linac) software systems, and/or image guidance systems and the Protura Couch. The system is intended to support a treatment table and add pitch and roll to normal
When an error message remains displayed and is not cleared in the Protura software with the Elekta pedestal coordinates, moving the pedestal could cause the Protura software to no…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Med Tec Inc recalled Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1, MT6X… - a moderate-severity action.
Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1, MT6X… was recalled by Med Tec Inc in February 28, 2018. Reason: When an error message remains displayed and is not cleared in the Protura software with the Elekta pedestal c…. Check the official notice for the remedy. Verify recall #Z-0671-2018 with the FDA Devices before acting.
The recall
Med Tec Inc issued this moderate-severity FDA Devices recall-When an error message remains displayed and is not cleared in the Protura software with the Elekta pedestal c….
- Moderate
- severity level
- Class II
- classification
- February 28, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0671-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0671-2018) was formally reported on February 28, 2018, with the manufacturer initiating the action on November 8, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Med Tec Inc is listed as the recalling firm, operating out of Orange City, IA. Federal records list the affected scope as 5 installations.
The documented reason for this recall is: When an error message remains displayed and is not cleared in the Protura software with the Elekta pedestal coordinates, moving the pedestal could cause the Protura software to not update with the pedestal location and … Distribution data in the federal record shows the product reached: US Distribution to Iowa and South Dakota. Shipped internationally to the Netherlands.. 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
5 installations
Related Recalls
6
3 from same agency
Product description
Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1, MT6XSM1.4.0-2, MT6SXM1.4.0-3, MT6XSM1.5.0-2, MT6XSM1.6.0-1, MT6XSM1.7.2, MT6XSM1.7.2-1, MT6XSM1.7.2-3, MT6XSM1.7.3, MT6XSM1.7.3-1, MT6XSM1.7.3-3. The Protura Software is intended to interface between record and verify systems, linear accelerator (Linac) software systems, and/or image guidance systems and the Protura Couch. The system is intended to support a treatment table and add pitch and roll to normal X, Y, Z and yaw motions to provide 6-degree axis movement. The product includes an interface between the treatment planning system and the treatment table to direct the table motion based on coordinates supplied. These products connect or support a treatment table by use of various mounting plates.
Reason for recall
When an error message remains displayed and is not cleared in the Protura software with the Elekta pedestal coordinates, moving the pedestal could cause the Protura software to not update with the pedestal location and buffers the pedestal movement history.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0671-2018 |
| Date reported | February 28, 2018 |
| Date initiated | November 8, 2017 |
| Recalling firm | Med Tec Inc |
| Firm location | Orange City, IA |
| Affected scope | 5 installations |
| Distribution | US Distribution to Iowa and South Dakota. Shipped internationally to the Netherlands. |
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-0671-2018) 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? ▼
Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1, MT6XSM1.4.0-2, MT6SXM1.4.0-3, MT6XSM1.5.0-2, MT6XSM1.6.0-1, MT6XSM1.7.2, MT6XSM1.7.2-1, MT6XSM1.7.2-3, MT6XSM1.7.3, MT6XSM1.7.3-1, MT6XSM1.7.3-3. The Protura Software is intended to interface between record and verify systems, linear accelerator (Linac) software systems, and/or image guidance systems and the Protura Couch. The system is intended to support a treatment table and add pitch and roll to normal X, Y, Z and yaw motions to provide 6-degree axis movement. The product includes an interface between the treatment planning system and the treatment table to direct the table motion based on coordinates supplied. These products connect or support a treatment table by use of various mounting plates.. Recalled by Med Tec Inc. Units affected: 5 installations.
Why was this product recalled? ▼
When an error message remains displayed and is not cleared in the Protura software with the Elekta pedestal coordinates, moving the pedestal could cause the Protura software to not update with the pedestal location and buffers the pedestal movement history.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 28, 2018. Severity: Moderate. Recall number: Z-0671-2018.
Where was the recalled product distributed? ▼
Distribution: US Distribution to Iowa and South Dakota. Shipped internationally to the Netherlands..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0671-2018) 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 February 28, 2018. 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.