Events

Recall of Device Recall Radrex i

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Toshiba American Medical Systems.

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
    77888
  • Event Risk Class
    Class 2
  • Event Number
    Z-3111-2017
  • Event Initiated Date
    2017-03-23
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158136
  • 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
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • Reason
    It was discovered during a procedure that when the operator made an exposure on the wireless x-ray detector and the image data was sent to the digital radiography system, and error message was displayed " system error (2063)" which required a reboot and loss of the image.
  • Action
    Toshiba America Medical Systems Inc. planned action to bring defect into compliance: 1.You will issue a Customer Notification Letter to make customers aware of the hazards, what measures will be taken to remedy the defect at no cost to the user, and how to safely use the equipment before corrections can be made. 2.You will install modified firmware on the systems to correct the defect and prevent recurrence. 3.You will provide progress reports on the effectiveness of the plan. If you have any questions, please feel free to contact your local Toshiba representative at (800) 421-1968.

Device

Device Recall Radrex i
  • Model / Serial
    Serial No. W8B1572022
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA (nationwide) Distribution
  • Product Description
    Toshiba Medical Radrex - i Digital Radiography X-ray system || Radrex-i is intended for use in conjunction 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 trans mission/ output of images to external devices.
  • Manufacturer
    Toshiba American Medical Systems

Manufacturer

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