Device Recall Protura Software which utilizes Elektas iCOM interface: MT6XSM1.4.0, MT6XSM1.4.01, MT6XSM1.4.02, MT6SXM1.4.

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

Radiology Devices

2

No

US Distribution to Iowa and South Dakota. Shipped internationally to the Netherlands.

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.