Events

Recall of Rational Imaging TM Software, model Ultra 10 || PACS System Version 7.1.Xx

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Canon USA 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
    26260
  • Event Risk Class
    Class 2
  • Event Number
    Z-0905-03
  • Event Initiated Date
    2003-03-11
  • Event Date Posted
    2003-06-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-05-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27395
  • 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
    Device, Digital Image Storage, Radiological - Product Code LMB
  • Reason
    Imaging archive system software mismatches images and patient names.
  • Action
    Recall letters were sent March 11, 2003. Another mailing was sent March 26, 2003 with stickers and preventative practice suggestions. A software fix will be available to customers in the near future.

Device

Rational Imaging TM Software, model Ultra 10 || PACS System Version 7.1.Xx
  • Model / Serial
    RIUpdate 7.1.0K
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    States of IA, CA , AR, WA, OR
  • Product Description
    Rational Imaging TM Software, model Ultra 10 || PACS System Version 7.1.Xx
  • Manufacturer
    Canon USA Inc

Manufacturer

Canon USA Inc
  • Manufacturer Address
    Canon USA Inc, 15955 Alton Parkway, Irvine CA 92618
  • Source
    USFDA