Events

Recall of Device Recall Protura Robotic Couch System Software, versions 1.6.1, 1.7.0, and 1.7.1

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
    73692
  • Event Risk Class
    Class 2
  • Event Number
    Z-1992-2016
  • Event Initiated Date
    2016-03-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144762
  • 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 using the recalled product in split shift mode, the non-sub-millimeter positioning has been found to be inconsistent with the setting parameters.
  • Action
    Civco Medical Solutions sent a "Urgent Field Correction Notice" dated March 31, 2016, to all affected customers. The letter identified the product the problem and the action need to be taken by the customer. The software's other configuration, "All 6 Degrees Protura" does not have the same translational issues. The firm send notification letters on February 23, 2016. In this letter, the Product Manager verified each site's software is configured to this operational mode which operates without the identified problem. In a later and separate notification on March 31, 2016, the firm informed customers that a new software version will be installed to address the problem. No timeframe was given in the letter. For further questions, please call ( 712) 737-8688.

Device

Device Recall Protura Robotic Couch System Software, versions 1.6.1, 1.7.0, and 1.7.1
  • Model / Serial
    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)
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution including the countries of Switzerland, Germany..
  • Product Description
    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
  • Manufacturer
    Med Tec Inc

Manufacturer

Med Tec Inc
  • Manufacturer Address
    Med Tec Inc, PO Box 320, 1401 8th St SE, Orange City IA 51041-7463
  • Manufacturer Parent Company (2017)
    Roper Technologies Inc
  • Source
    USFDA