Events

Recall of Device Recall CT system

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
    67227
  • Event Risk Class
    Class 2
  • Event Number
    Z-0972-2014
  • Event Initiated Date
    2013-12-11
  • Event Date Posted
    2014-03-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125035
  • 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, x-ray, tomography, computed - Product Code JAK
  • Reason
    Toshiba america medical systems, inc. initiated this recall due to the failure of the parts used in the x-ray high-voltage generator. in some cases, x-ray exposure cannot be performed.
  • Action
    Toshiba America Medical Systems, Inc. initiated this recall by sending "Urgent Medical Device Correction," letter dated December 11, 2013, informed customers of the recall by providing, the device name, serial number, problem statement, corrective action statement, and contact information. A customer reply form accompanied the recall notification letter. Strategy: The majority of the letters are sent via USPS return receipt mail. The letter contains a return reply form that is to be faxed to TAMS for retention. After two weeks contact will be made with each non responding location and a copy of the letter will be faxed to that location and the fax receipt will service as proof of notification. Upon release of the new part it will be assigned to a TAMS employee with instructions for implementation at each site. Each incident is assigned a unique task number and each task is tracked through to completion. In the event that a customer refuses the installation of the corrected software/hardware the customer would be requested to sign a service case record stating that the corrected software/hardware was refused. CDRH approves the CAP subject to the following condition: Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. For further questions please call (714) 730-5000.

Device

Device Recall CT system
  • Model / Serial
    SERIAL NO.: 1CB1262006, 1DB1312033, 1DC1352070, 1DB1342060, 1DB1332049, 1DC1382081, 1DB1312027, 1DB1332045, 1DC1362073, 1CB12X2018.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of: MD, WV, OH, CA, MN, IN, NY and WI.
  • Product Description
    TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray 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 92780-7047
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    USFDA