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U.S. Department of Health and Human Services

Class 2 Device Recall Protura Software which utilizes Elektas iCOM interface: MT6XSM1.4.0, MT6XSM1.4.01, MT6XSM1.4.02, MT6SXM1.4.

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  Class 2 Device Recall Protura Software which utilizes Elektas iCOM interface: MT6XSM1.4.0, MT6XSM1.4.01, MT6XSM1.4.02, MT6SXM1.4. see related information
Date Initiated by Firm November 08, 2017
Create Date February 21, 2018
Recall Status1 Terminated 3 on August 21, 2020
Recall Number Z-0671-2018
Recall Event ID 79182
510(K)Number k132084  
Product Classification Couch, radiation therapy, powered - Product Code JAI
Product 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.
Code Information 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
Recalling Firm/
Med Tec Inc
1401 8th St SE
Orange City IA 51041-7463
For Additional Information Contact
Manufacturer 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.
FDA Determined
Cause 2
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 in Commerce 5 installations
Distribution US Distribution to Iowa and South Dakota. Shipped internationally to the Netherlands.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAI and Original Applicant = MED-TEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS