Proutra™ MT6XSM1.7.3Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841439111376), received between Oct 11, 2017 and Oct 11, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Application Program Problem” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K132084); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2017Computer Software Problem; Application Program Problem; Device Operates Differently Than Expected; Computer Software Problem; Application Program Problem; Device Operates Differently Than Expected

  (B)(4), FACILITY IN (B)(6), REPORTED THE PROTURA SYSTEM BEGAN TO UNEXPECTEDLY MOVE AFTER A 6-DEGREE CORRECTION WAS APPLIED AND PATIENT TREATMENT WAS STARTED. THIS CAUSED THE LINEAR ACCELERATOR TO STOP TREATMENT AND THE PATIENT WAS REALIGNED TO THE CORRECT POSITION AND TREATMENT CONTINUED. UPON INVESTIGATION, IT WAS DETERMINED THAT THE MOVE OF THE PROTURA WAS FROM AN ERROR MESSAGE FROM A PRIOR PATIENT TREATMENT (ERROR MB-ERR-52, WHICH WAS NOT CLEARED), AND WHILE THIS ERROR MESSAGE WAS PRESENT, THE PROTURA SOFTWARE BUFFERED ICOM DATA. THE ICOM DATA CONTAINS THE PEDESTAL LOCATION. SINCE THE ERROR MESSAGE WAS ACTIVE DURING 2 ADDITIONAL PATIENT TREATMENTS, THE PEDESTAL MOVEMENT CONTINUED TO BE BUFFERED WHILE POSITIONING THESE INTERIM PATIENTS, THE PEDESTAL MOTION WAS THEN PROCESSED BY PROTURA SOFTWARE ONCE THE ERROR WAS CLEARED. THE 'CATCH-UP' PROCESSING IS WHAT LEAD TO PROTURA HAVING A DELAYED RECOGNITION TO THE PEDESTAL MOTION, WHICH THEN LEAD TO AN UNEXPECTED ACTIVATION OF THE PROTURA AUTO LOAD/UNLOAD FEATURE. THIS PROBLEM OCCURRED BECAUSE THE SOFTWARE THREAD HANDING THE ICOM MESSAGES, WHICH ARE SPECIFIC TO ELEKTA LINACS, STOPPED LOOPING WHEN THE MB-ERR-52 ERROR MESSAGE WAS DISPLAYED

  Patient problems: Cancer

  MAUDE report 6941986 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132084. One submission often covers many models, so check the product and lot details in each record.

• Z-0671-2018 · Nov 8, 2017 · 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
• Z-1992-2016 · Mar 31, 2016 · Terminated
  Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1.7.1 (Part Number MT6XSM1.7.1), CIVCO, Orange City, IA 51041