Events

Recall of SSH880CV Aplio Artida 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
    55774
  • Event Risk Class
    Class 2
  • Event Number
    Z-1955-2010
  • Event Initiated Date
    2009-09-16
  • Event Date Posted
    2010-07-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91753
  • 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, imaging, pulsed doppler, ultrasonic - Product Code IYO
  • Reason
    Toshiba america medical systems (tams) is initiating a field correction on the ssh-880cv aplio artida system due to a problem related to a wrong measurement value display in using with dicom viewer. when an image is transferred from this system in dicom transfer and a measurement is performed on a doppler image in the dicom viewer, measured values such as vti (velocity time integral) and pi/ri.
  • Action
    The software will be replaced. To accomplish this, Toshiba America Medical Systems (TAMS) will notify consignees via USPS return receipt mail. The letter contains a return reply form that is to be faxed to TAMS for retention. For questions or concerns, please contact your Toshiba representative or the firm at (714) 730-5000.

Device

SSH880CV Aplio Artida System
  • Model / Serial
    2031, 2032, 2033, 2048, 2049, 2056, 2069, 2070, 2071, 2072, 2073, 2074, 2075, 2076, 2077, 2078, 2079, 2080, 2087, 2088, 2103, 2104, 2105, 2106, 2707, 2108, 2119, 2120, 2123, 2124, 2204, 2205, 2206
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide ((CA, GA, IA, LA, MA, MD, MN, MT, PA, PR, OH, OR, TN).
  • Product Description
    SSH-880CV Aplio Artida System
  • Manufacturer
    Toshiba American Medical Systems Inc

Manufacturer

Toshiba American Medical Systems Inc
  • Manufacturer Address
    Toshiba American Medical Systems Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92781-2068
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    USFDA