Events

Recall of INFX8000V

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
    73078
  • Event Risk Class
    Class 2
  • Event Number
    Z-0752-2016
  • Event Initiated Date
    2015-08-14
  • Event Date Posted
    2016-02-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143016
  • 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
    Interventional fluoroscopic x-ray system - Product Code OWB
  • Reason
    When a fontal da (digital angiography) acquisition was done, scattered x-ray came into the dose meter on the lateral side. as a result, the dose meter sent a minus value to the software. consequently, the software defined the data as an "abnormal value" and it stopped displaying dose data and the dose data was lost. the following message was displayed, "dose meter abnormal, dose info disabled".
  • Action
    Toshiba's planned action to bring into compliance: 1.Affected customers will be notified using the Customer Notification Letter you provided, 2. revised system software will be installed on the systems to prevent this occurrence from happening, 3. the corrections will be made free of charge, and 4. the corrections will be completed by April 4, 2016. For further questions, please call 1- 800 521-1968.

Device

INFX8000V
  • Model / Serial
    Serial Numbers ACA1492002, AAA1492001, W4B1442020, and W4B1432018.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution to OH and NY
  • Product Description
    INFX-8000V Bi-Plane X-Ray Interventional System || X-ray systems
  • 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