Events

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

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Med Tec Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79182
  • Event Risk Class
    Class 2
  • Event Number
    Z-0671-2018
  • Event Initiated Date
    2017-11-08
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161544
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Couch, radiation therapy, powered - Product Code JAI
  • 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.
  • 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.

Device

Device Recall Protura Software which utilizes Elektas iCOM interface: MT6XSM1.4.0, MT6XSM1.4.01,...
  • Model / Serial
    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
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to Iowa and South Dakota. Shipped internationally to the Netherlands.
  • Product Description
    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.
  • Manufacturer
    Med Tec Inc

Manufacturer

Med Tec Inc
  • Manufacturer Address
    Med Tec Inc, 1401 8th St SE, Orange City IA 51041-7463
  • Manufacturer Parent Company (2017)
    Roper Technologies Inc
  • Source
    USFDA