Events

Recall of Device Recall AlignRT

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Vision Rt 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
    70009
  • Event Risk Class
    Class 2
  • Event Number
    Z-0934-2015
  • Event Initiated Date
    2014-11-11
  • Event Date Posted
    2015-01-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132106
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Reason
    Potential use error when the external gate controller is turned on after the vision rt software has been opened.
  • Action
    VisionRT sent an Urgent Medical Device Correction Notification letter dated November 10, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers shall: A. Print the instructions in Appendix 3, place them in the front of the product guide and ensure these instructions are read and understood by all those who need to be aware of them within their organisation; B. Maintain awareness of this issue until all actions indicated in this letter have been successfully completed; C. Promptly inform Vision RT if they believe that patient harm occurred due to this issue; AND D. Complete the acknowledgement in Appendix 1 and return it via email to corrections@visionrt.com. Contact Vision RT Should you have any queries on this letter, please do not hesitate to contact Vision RT by telephone on +44 20 83464300 (866 778-2379 from the US) or as per http://www.visionrt.com/contact/details. For questions regarding this recall call 866-594-5443.

Device

Device Recall AlignRT
  • Model / Serial
    Serial numbers (internally referred to as PCR numbers):   USA: 247-018, 247-039, 247-040, 247-053, 247-060, 247-061 , 247-062, 247-063, 247-068, 247-071 , 247-075, 247-076 , 247-078, 247-081, 247-083, 247-096, 247-099, 247-100,, 247-101, 247-102 , 247-110 , 247-118, 247-119, 247-122, 247-124, 247-127, 247-129, 247-130, 247-138, 247-140, 247-142, 247-149, 247-150, 247-153, 247-161, 247-167, 247-171, 247-184, 247-194, 247-200, 247-207, 247-212, 247-213, 248-012, 248-018, 248-041  Rest of the world:  247-035, 247-073, 247-114, 247-131, 247-147, 247-148, 247-188
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment.
  • Manufacturer
    Vision Rt Inc

Manufacturer

Vision Rt Inc
  • Manufacturer Address
    Vision Rt Inc, 8840 Stanford Blvd, Columbia MD 21045-5827
  • Source
    USFDA