Events

Recall of Device Recall Aplio XG

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Toshiba American Med Sys 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
    45811
  • Event Risk Class
    Class 2
  • Event Number
    Z-0305-2008
  • Event Initiated Date
    2007-10-02
  • Event Date Posted
    2008-01-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66198
  • 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
    Panel lock-up: when using dynamic image acquisition modes the panel may lock up, if the operator attempts to perform a still image capture. if the panel locks up the system will have to be rebooted to continue the examination which may cause a delay in completion of the patient examination.
  • Action
    Notification letters, Urgent Medical Device Correction, with an attached Customer Response form were sent to customers beginning on October 2, 2007. Customers were notified this action was being taken as a result of an investigation that resulted from a software issue that was found by the manufacturer. Customers were informed that a Toshiba Customer Service Engineer would contact them to schedule a software upgrade when the software becomes available. If customers have any questions they were instructed to contact their or call (800) 421-1968 and ask for the Regulatory Affairs Department.--A short term instruction included "Avoid using the Freeze Key when performing dynamic image acquisitions"

Device

Device Recall Aplio XG
  • Model / Serial
    SERIAL NUMBERS: 99B0752571, 99B0752572, 99B06Z2073, 99B06Z2102, 99B06Z2107, 99B0722268, 99B0722269, 99B0722270, 99B0722271, 99B0722272, 99B0732349, 99B0732350, 99B0732351, 99B0732352, 99B0732353, 99B0732354, 99B0722208, 99B0722250, 99B0752531, 99B0752532, 99B06Z2072, 99B0752508, 99B0752509, 99B0752510, 99B0752511, 99B0722251, 99B06Z2071, 99B0722206, 99B0722207, 99B0722204, 99B0752524, 99B0752525, 99B0732355, 99B0742413, 99B0742414, 99B0742415, 99B0742416, 99B0742417, 99B0722203, 99B06Z2062, 99B0722201, 99B0712171, 99B0722254, 99B0752507, 99B06Z2064, 99B06Z2104, 99B0712169, 99B0712172, 99B0722202, 99B0752570, 99B0752562, 99B0752563, 99B0752564, 99B0752565, 99B06Z2103, 99B0752523, 99B0752550, 99B06Z2074, 99B0712173, 99B0712174, 99B06Z2059, 99B0752551, 99B0752561, 99B06Z2108, 99B0752549, 99B0722205, 99B0752547, 99B0712168, 99B0722253, 99B06Y2048, 99B06Y2049, 99B06Y2051, 99B06Z2058, 99B06Z2067, 99B06Z2110, 99B06Z2116, 99B06Z2057, 99B06Z2088, 99B06Z2105, 99B06Z2111, 99B06Z2115, 99B0722252, 99B06Z2063, 99B06Z2065, 99B06Z2066, 99B06Z2090, 99B06Z2101, 99B06Z2113, 99B0712170, 99B06Z2060, 99B06Z2068, 99B06Z2070, 99B06Z2106, 99B0752548, 99B06Z2089, 99B06Z2091, 99B06Z2092, 99B06Y2050, 99B06Z2055, 99B06Z2056, 99B06Z2061, 99B06Z2069, 99B06Z2075, 99B06Z2109, 99B06Z2112, and 99B06Z2114
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide: USA including the states of AK, AZ, CA, FL, IA, IL, IN, KS, MI, MN, MO, MT, NE, NV, NY, OH, OR, PR, VA, WI & WV
  • Product Description
    Toshiba Aplio XG Diagnostic Ultrasound System, Model: SSA-790A with version 1.1 software, Toshiba America Medical Systems, Inc., Tustin, CA. 92780
  • Manufacturer
    Toshiba American Med Sys Inc

Manufacturer

Toshiba American Med Sys Inc
  • Manufacturer Address
    Toshiba American Med Sys Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92781-2068
  • Source
    USFDA