CLASS II Device recall · Reported 28 Feb 2018 · FDA Enforcement Report
Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0 recalled
Med Tec is recalling Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, distributed nationwide in the US. The recall was initiated on 8 Nov 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0671-2018
- FDA event ID
- 79182
- Recalling firm
- Med Tec, Orange City, IA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Nov 2017
- FDA classified
- 21 Feb 2018
- Reported
- 28 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 8 Nov 2017 | Recall initiated by company | |
| 21 Feb 2018 | Classified by FDA | +105 days |
| 28 Feb 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
US Distribution to Iowa and South Dakota. Shipped internationally to the Netherlands.
Questions about this recall
Is Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0 recalled?
Yes. Med Tec recalled Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0 on 8 Nov 2017. The recall is Class II and its status is Terminated. Recall number Z-0671-2018.
Why was it 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 lots are affected?
MT6XSM1.4.0, MT6XSM1.4.0-1, MT6XSM1.4.0-2, MT6SXM1.4.0-3, MT6XSM1.5.0-2, MT6XSM1.6.0-1, MT6XSM1.7.1 (M881920, M880610), MT6XSM1.7.2 (Lot M924170), MT6XSM1.7.2-1, MT6XSM1.7.2-3, MT6XSM1.7.3 (Lot M093990), MT6XSM1.7.3-1, MT6XSM1.7.3-3
Where was it sold?
US Distribution to Iowa and South Dakota. Shipped internationally to the Netherlands.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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