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Terminated

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.

FDA Recall Z-0671-2018 · Posted None

Recalling FirmMed Tec Inc
Recall StatusTerminated
Product CodeJAI
Date Initiated2017-11-08
Date Terminated2020-08-21
Product Quantity5 installations

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.

Firm 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.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K132084PROTURA COUCH SOFTWAREMed-Tec, Inc. D/B/A Civco Medical Solutions · 2013-09-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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