The Recall Desk
HighFDA (Devices)·Z-0671-2018·Announced 2018-02-28

Med Tec Protura Software Recalled for Pedestal Coordinate Errors

Med Tec Inc is recalling Protura software versions that may fail to update pedestal location data, potentially affecting treatment table movements.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device software defect that could affect treatment accuracy, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Med Tec Inc is recalling specific versions of Protura software that utilize Elekta's iCOM interface. The affected software versions include MT6XSM1.4.0 through MT6XSM1.7.3-3. This software is intended to interface between record and verify systems, linear accelerator software, and image guidance systems to support the Protura Couch treatment table.

The recall is due to a software error where, if an error message remains displayed and is not cleared, moving the pedestal may cause the software to fail to update with the current pedestal location. This issue can result in the software buffering the pedestal movement history, which may affect the accuracy of the treatment table's 6-degree axis movements.

The recall affects 5 installations distributed in Iowa and South Dakota, as well as one international shipment to the Netherlands. Users of the affected software should contact Med Tec Inc for instructions on how to resolve the issue.

The recalled product

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 interfac
Manufacturer
Med Tec Inc
Affected units
5

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (14)

  • 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

Distribution

Distributed in 2 states: