Events

Recall of Device Recall Shimadzu FDR Visionary Suite

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

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
    77351
  • Event Risk Class
    Class 2
  • Event Number
    Z-2655-2017
  • Event Initiated Date
    2017-05-23
  • 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=155811
  • 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, stationary - Product Code KPR
  • Reason
    Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
  • Action
    Shimadzu sent an Urgent Voluntary Medical Device Recall Notice to all affected customers. The firm will implement a voluntary recall/field corrective action to add protective parts preventing the x-ray tube assembly from coming into contact with the patient or operator should separation of the tube mounting flange from the tube holding shaft occur. Customers with questions were instructed to call 800-228-1429.

Device

Device Recall Shimadzu FDR Visionary Suite
  • Model / Serial
    Serial No. 0162M4501 thru 0562M45103, 3ZC5C2A0C002 thru 3ZC5C1734001, D362M42902 thru 0562M41101, 41E733E69003, MP95A8F5A001 thru MP95A9F6B001
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - Nationwide distribution to AK, AR, AZ, CA, CT, FL, IL, IN, KS, LA, MI, MO, NE, NJ, NM, NV, NY,OH, OK, PA, RI, SC, TN, TX, WA, WI, and Hawaii Foreign: Canada and Japan
  • Product Description
    SHIMADZU FDR Visionary || Catalog Number: FDR Visionary Suite || Stationary x-ray system for taking general radiographic and tomographic images of the whole body. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals
  • Manufacturer
    Shimadzu Medical Systems Usa Com

Manufacturer

Shimadzu Medical Systems Usa Com
  • Manufacturer Address
    Shimadzu Medical Systems Usa Com, 20101 S Vermont Ave, Torrance CA 90502-1328
  • Manufacturer Parent Company (2017)
    Shimadzu Corp.
  • Source
    USFDA