Recall Z-0671-2018 ยท JAI Couch, Radiation Therapy, Powered
Med Tec Inc
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 Pro
| Date | Nov 8, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | Customers were notified via email on about November 8, 2017. Instructions include to contact Civco Medical Solutions to arrange an update to the device. Until the update is accomplished, customers were instructed to review and acknowledge the notification, verify the actual pedestal location matches the pedestal location being locked into Protura software, and disable the auto load/zero functionality described in the IFU. For further questions, please call (712) 737-8688. |
| Quantity | 5 installations |
| Distribution | US Distribution to Iowa and South Dakota. Shipped internationally to the Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132084 | PROTURA COUCH SOFTWARE Med-Tec, Inc. D/B/A Civco Medical Solutions, Sep 26, 2013 |