Events

Recall of Device Recall Best Theratronics cabinet xray systems

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by BEST THERATRONICS 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
    74637
  • Event Risk Class
    Class 2
  • Event Number
    Z-2251-2016
  • Event Initiated Date
    2016-05-06
  • Event Date Posted
    2016-07-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148078
  • 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
    Irradiator, blood to prevent graft versus host disease - Product Code MOT
  • Reason
    It was discovered that both the new device and the predicate device failed to comply with performance standard.
  • Action
    Best Theratronics ( BTL) planned action to bring into compliance: BTL proposes that the repairs are to be completed during annual routine preventive maintenance visits at the user's site to minimize downtime, which disrupts the user's ability to irradiate blood. A standard repair kit has been developed. For further information, please contact Best Theratronics Customer Service at 1-866-792-8598

Device

Device Recall Best Theratronics cabinet xray systems
  • Model / Serial
    All Raycell units with serial #'s 5000 and higher.
  • Product Classification
    Radiology Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease.
  • Manufacturer
    BEST THERATRONICS LTD.

Manufacturer

BEST THERATRONICS LTD.
  • Manufacturer Address
    BEST THERATRONICS LTD., 413 MARCH ROAD, KANATA Canada
  • Manufacturer Parent Company (2017)
    Best Theratronics Ltd
  • Source
    USFDA