Events

Recall of Device Recall Access ClearVue Prone Breast Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Wfr/aquaplast Corp.

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
    73543
  • Event Risk Class
    Class 2
  • Event Number
    Z-1264-2016
  • Event Initiated Date
    2016-01-07
  • Event Date Posted
    2016-03-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144438
  • 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
    Some of the access clearvue prone breast devices may contain scales that are misaligned from the zero reference with respect to other access clearvue prone breast devices. this can result in differences in scale orientation.
  • Action
    Qfix sent a Field Safety Notification letter dated January 7, 2016 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached Inventory Survey form and mail it back. For questions call (610) 268-0585.

Device

Device Recall Access ClearVue Prone Breast Device
  • Model / Serial
    device model numbers: RT-4545CV-17, RT-4545CV-20
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of NY, PA, CA, IL, and TX. Foreign Countries: Singapore, Australia, Saudi Arabia, and Spain.
  • Product Description
    Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device || Product Usage: || Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device is a medical charged-particle radiation therapy system. A breast radiation therapy patient support, is an accessory for medical linear accelerator radiation therapy. It may be used with CT and MR scanners to acquire images for radiation therapy planning.
  • Manufacturer
    Wfr/aquaplast Corp

Manufacturer

Wfr/aquaplast Corp