Derived label

Device software or design

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.device_software_design

v1.0.0

Assignment summary

Mode key: device_software_design
Evidence excerpt: software with the Elekta pedestal coordinates, moving the pedestal could cause
Rule explanation: Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm: Med Tec Inc