Events

Recall of Device Recall Toshiba DRAD3000E FPD Wireless system

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Toshiba American Medical Systems 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
    73064
  • Event Risk Class
    Class 2
  • Event Number
    Z-1175-2016
  • Event Initiated Date
    2016-01-14
  • Event Date Posted
    2016-03-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142948
  • 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
    System, x-ray, fluoroscopic, image-intensified - Product Code JAA
  • Reason
    When a user performed radiography using the wireless fpd, a message window appeared on the monitor stating that imaging transmission was not completed with no radiographic image. it also indicated to select the "ok" button to re-acquire the image data or to select the¿'cancel" button to cancel the re-acquisition. as instructed the user selected "ok" and the same message window appeared. this same operation was repeated several times with the identical result - no image. finally, the user selected "cancel" and the re-acquisition was terminated.
  • Action
    Toshiba's planned action: 1."Toshiba America Medical Systems, Inc. (TAMS) will advise contact customers to stop using the system if any abnormalities are found using the system. 2. TAMS will install the software and perform testing to ensure the software update was effective. 3. The customer notification letter which includes a statement that TAMS will without charge, remedy the defect or bring the product into compliance. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. TAMS will implement this CAP by June 30, 2016. Customers with questions were advised to call 301-796-5910. For questions regarding this recall call 714-730-5000.

Device

Device Recall Toshiba DRAD3000E FPD Wireless system
  • Model / Serial
    Serial number : USB1522023
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution to PA, UT, FL, NY, LA, WV, NJ, OH, WI and TX.
  • Product Description
    Toshiba DRAD-3000E FPD Wireless System || Product Usage The DRAD-3000¿ is intended for use with the ceiling-suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck, and limbs. This system is used for image acquisition, image display and transmission/output or images to external devices.
  • Manufacturer
    Toshiba American Medical Systems Inc

Manufacturer

Toshiba American Medical Systems Inc
  • Manufacturer Address
    Toshiba American Medical Systems Inc, PO Box 2068, 2441 Michelle Dr, Tustin CA 92780-7047
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    USFDA