Events

Recall of Toshiba America Medical Systems Inc Aplio Artida;

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
    55466
  • Event Risk Class
    Class 2
  • Event Number
    Z-2179-2011
  • Event Initiated Date
    2010-04-20
  • Event Date Posted
    2011-05-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90928
  • 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
    Diagnostic Ultrasound System - Product Code IYN
  • Reason
    There is a possibility of the system shutting down owing to the power supply unit causing the protection function to activate thus turning off the system prematurely.
  • Action
    The recall was initiated on 4/20/10 with Toshiba America Medical Systems (TAMS) forwarding a Medical Device Correction with a Customer Reply Form (via US Postal Service for US Customers) to all customers who purchased the SSH-880CV Aplio Artida Diagnostic Ultrasound System. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to avoid this problem until corrective action is taken, in case this problem occurs; please contact their Toshiba Representative. If emergency use is necessary, use the following procedure which allows the system to be used temporarily: 1. Turn OFF the breaker at the back of the system and confirm that the error code near the breaker disappears. 2. Turn ON the breaker again to supply power to the system. Customers were instructed to complete and return the attached form and fax it to the toll free number at the top of the form. This form can also be sent via email to raffairs@tams.com. If customers had any questions they can call Paul Biggins at (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968.

Device

Toshiba America Medical Systems Inc Aplio Artida;
  • Model / Serial
    W1F09X2272, W1F0972220, W1F0992260, W1F0992262, W1H1012311, W1F0972219, W1F09Y2281, W1F0972218, W1F09X2270, W1F09X2271, W1F09Y2280, W1F09X2268, W1F09X2273, W1F09Y2282, W1F09Z2296, W1F09Z2297, W1F0992261
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA, including Puerto Rico.
  • Product Description
    Toshiba America Medical Systems Inc. SSH-880CV Aplio Artida; Diagnostic Ultrasound 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