Reported Feb 28, 2018 · Terminated
Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1, MT6XSM1.4.0-2, MT6SXM1.4.0-3,…
Med Tec Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Med Tec Inc · 1401 8th St SE · Orange City, IA · 51041-7463
Is this the product you have?
- Protura Software
- which utilizes Elekta's iCOM interfaceMT6XSM1.4.0, 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
- Lot codes and dates
MT6XSM1.4.0MT6XSM1.4.0-1MT6XSM1.4.0-2MT6SXM1.4.0-3MT6XSM1.5.0-2MT6XSM1.6.0-1MT6XSM1.7.1 (M881920M880610)MT6XSM1.7.2 (Lot M924170)MT6XSM1.7.2-1MT6XSM1.7.2-3MT6XSM1.7.3 (Lot M093990)MT6XSM1.7.3-1MT6XSM1.7.3-3
- Amount recalled
- 5 installations
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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