Events

Recall of Toshiba AQUILION ONE

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
    57499
  • Event Risk Class
    Class 2
  • Event Number
    Z-1257-2011
  • Event Initiated Date
    2010-09-07
  • Event Date Posted
    2011-02-15
  • 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=96386
  • 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
    X-Ray CT Scanner - Product Code JAK
  • Reason
    Incorrect dose calculation. the software that performs the pre-scan dose calculation uses an incorrect parameter for an exam plan using a tube voltage of 80kv or 100kv. this results in a pre-scan expected dose that is approximately 10% lower than what the displayed value should be when the scanner executes the exam plan.
  • Action
    Toshiba America Medical Systems (TAMS) issued notification to consignees 9/7/2010, via USPS return receipt mail. The letter contains a return reply form that is to be faxed to TAMS as proof of notification.

Device

Toshiba AQUILION ONE
  • Model / Serial
    Affected Serial No.: 2DA0872038, 2DA0962116, 2DA0862034, 2DA09Z2161, 2DA07X2008, 2DA1012165, 2DA08X2072, 2DA09Y2151, 2DA0842023, 2DA07X2005, 2DA1012168, 2DA08X2067, 2DA0882053, 2DA0862036, 2DA08Z2092, 2DA0882051, 2DA09Z2162, 2DA1072211, 2DA09X2143, 2DA08Y2077,2DA09X2139, 2DA08X2070, 2DA0982133 2133, 2DA0842026, 2DA0882052, 2DA0972123, 2DA08Y2080, 2DA0882048, 2DA08X2063, 2DA09Y2148, 2DA1012170, 2DA08X2071, 2DA1012169, 2DA0952115, 2DA0982131, 2DA07Y2010, 2DA08X2061, 2DA1012167, 2DA0882049, 1DA0962006, 1DA09Y2014, 1DA0992011, 1DA0972007, 1DA0972008, 2DA1012166, 2DA09Z2158, 2DA1072212, 2DA1012174, 2DA0792004, 2DA1062208, 2DA0792002, 1DA1062015, 1DB1072012
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution.
  • Product Description
    Toshiba TSX-301A AQUILION ONE (MPDCT0297EA) - Whole Body X-Ray CT Scanner
  • 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