BEUDAMED
    FDA Enforcement Class II Terminated

    TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.

    Recall: Z-0972-2014 · Reported March 12, 2014

    Enforcement

    Recall Number
    Z-0972-2014
    Event ID
    67227
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Toshiba American Medical Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 12, 2014
    Initiation Date
    December 11, 2013
    Classification Date
    March 6, 2014
    Termination Date
    October 16, 2014
    Address
    2441 Michelle Dr, P.O. Box 2068, Tustin, CA, 92780-7047, United States

    Description

    TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.

    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.

    Code Info

    SERIAL NO.: 1CB1262006, 1DB1312033, 1DC1352070, 1DB1342060, 1DB1332049, 1DC1382081, 1DB1312027, 1DB1332045, 1DC1362073, 1CB12X2018.

    Distribution

    US Distribution including the states of: MD, WV, OH, CA, MN, IN, NY and WI.

    Quantity

    8 units