Events

Recall of Xario Diagnostic Ultrasound System SSA660A

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
    66059
  • Event Risk Class
    Class 2
  • Event Number
    Z-0119-2014
  • Event Initiated Date
    2013-08-05
  • Event Date Posted
    2013-10-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-06-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121394
  • 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 IYN
  • Reason
    The firm initiated this recall of certain toshiba diagnostic ultrasound systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2d+pw mode or 2d+cdi (power, adf) +pw mode. when the system is used under both conditions listed below, the temperature of the transducer head connected to the system may increase in temperature and possibly.
  • Action
    Toshiba sent an Urgent Medical Device Correction letter dated August 5, 2013. along with a Reply Form via USPS return receipt mail. The letter identified the product, the problem, and the action to be taken by the customer. Until the software is corrected customers were instructed to change the preset settings as described in the letter. Customers were asked to complete and return the attached form and fax it to the toll free number. The form also can be sent via email to raffairs@tams.com Customers with questions were instructed to call 800-421-1968 or contact their local Toshiba Representative at 800-521-1968. For questions regarding this recall call 714-730-5000.

Device

Xario Diagnostic Ultrasound System SSA660A
  • Model / Serial
    Lot Numbers not utilized. Serial Numbers: LGA0792628 LGA0792564 LGA0792565 LGA0792531 LGA0792540 LGA0792541 LGA0792617 LGA0792554 LGA0792626 LGA0792627 LGA0792552 LGA0792616 LGA0792563 LGA0792553 LGA0792615 LGA0792551 LGA0792613
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including and US Territory Puerto Rico
  • Product Description
    Xario Diagnostic Ultrasound System SSA-660A || Used for routine diagnostic imaging
  • 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 92780-7047
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    USFDA