Events

Recall of Device Recall TrueBeam Radiotherapy Delivery System and EDGE Radiotherapy Delivery System,

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Vision RT Ltd.

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
    74607
  • Event Risk Class
    Class 2
  • Event Number
    Z-2668-2016
  • Event Initiated Date
    2016-06-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148234
  • 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
    Vision rt ltd received three (3) reports from different sites that discovered the following issue, unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up for the optical surface monitoring system [osms]. 1. crm 3194, no serious injury, no mdr, aware date: dec 11, 2015 2. crm 3321, no patient involved, no mdr, aware date: jan 19, 2016 3. crm 4570, no serious injury, no mdr, aware date: march 15, 2016 no patient harm was reported in any of these cases.
  • Action
    Vision RT Ltd will provide all affected AlignRT¿ Plus Users with an Urgent Medical Device Correction Notification letter, dated 2016-06-24 Subject: Unexpected Overwrite of Plan Couch Parameter. The letter will provide Users with a detailed description of the problem and provide instructions to avoid the issue. Non-responders will be notified again until we achieve 100% for North America and International consignees. Vision RT will make three (3) attempts using at least two different methods of contact to obtain proof of notification. Containment: Vision RT will provide a copy of the Urgent Medical Device Correction letter for any site accepting an AlignRT device. The letter will provide Users with a detailed description of the problem and provide instructions to avoid the issue. Product will not be returned to Vision RT. Varian Medical Systems and Vision RT are investigating development of a technical fix for the affected products. Notification of the intention to correct is provided in the Urgent Medical Device Correction Notification letter, dated 2016-06-24 Subject: Unexpected Overwrite of Plan Couch Parameter. Vision RT Ltd will contact all affected AlignRT¿ Plus users and schedule upgrades to implement the correction when available.

Device

Device Recall TrueBeam Radiotherapy Delivery System and EDGE Radiotherapy Delivery System,
  • Model / Serial
    Serial Number of the device(s) distributed 248-016 248-021 248-022 248-030 248-038 248-041 248-063 248-064 249-1514 249-1516 248-071 249-0239 248-073 248-080 248-084 249-0043 249-0055 249-0056 249-0058 249-0069 249-0130 249-0137 249-1509 249-0141 249-0275 249-0152 249-0162 249-0169 249-0251 249-0253 249-0254 249-0288 249-1503 249-1512 249-1518 249-TBD 249-0061 249-0131 249-0256 249-0289 249-0290 249-TBD 248-083 249-0273 249-0276 249-1500 249-1519
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product distributed in US. The foreign countries where the product was distributed are as follows: Canada, Germany, Japan, Sweden, Switzerland, Taiwan, and United Kingdom. No product was distributed to US government accounts.
  • Product Description
    TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.
  • Manufacturer
    Vision RT Ltd

Manufacturer

Vision RT Ltd