Events

Recall of Device Recall Aplio

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
    37965
  • Event Risk Class
    Class 2
  • Event Number
    Z-0986-2007
  • Event Initiated Date
    2007-02-02
  • Event Date Posted
    2007-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52533
  • 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
    Ultrasound - Product Code IYN
  • Reason
    When using the lv measurement function and making numerous measurements the value displayed on the image screen may on occasion not update correctly. the values that are stored in mda (measurement display area) are correct and no issue has been reported with these values.
  • Action
    Notification letters were sent to customers on February 2, 2007. Customers were informed of the safety issue regarding the possibility of incorrect measurement values being displayed on the active image screen while performing multiple measurements and instructed to verify actual results against the values stored in the MDA (measurement display area). Customers were also informed that a Toshiba Customer Service Engineer will contact them to schedule a software upgrade when software becomes available. If customers have any questions they were instructed to contact their Toshiba Customer Service Engineer or call (800) 421-1968 and ask for the Regulatory Affairs Department. Customers were also instructed to distribute this information to all users of the product and also with the Bio-medical Department at their facility.

Device

Device Recall Aplio
  • Model / Serial
    Serial numbers:  B2622263,  B2622264,  B2622265, B2622267, B2622269,  B3522364, B3522365, B3522366, B3522369, B3522370, B3522372, B3522373, B3522402, B3522403, B3522404, B3522405, B3552542, B3552557, B3552558, B3552560, B3562595, B3562599, B3582672, B3582673, B3582674, C3592771, C3592772, C3592773, C3592774, D4553251, D4553252, D4553253, D4563327, D4563329, E4593563, E4593564, F4603654, F4603655, F4603656, F4613730, F4613731, F4613732, F5513813, G5523871 & G5523875
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Toshiba Aplio 50 Digital Ultrasound System, SSA-700A with version 6 software
  • 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