BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens Artis zee Ceiling Systems. Angiographic x-ray system.

    Recall: Z-1080-2014 · Reported March 5, 2014

    Enforcement

    Recall Number
    Z-1080-2014
    Event ID
    67175
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 5, 2014
    Initiation Date
    December 16, 2013
    Classification Date
    February 24, 2014
    Termination Date
    March 9, 2015
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355, United States

    Description

    Siemens Artis zee Ceiling Systems. Angiographic x-ray system.

    Reason

    During the lifetime of Artis zee Ceiling systems, there is an increased wear due to potential sub-optimal cable guidance that can lead to cable damage.

    Code Info

    Artis zee Ceiling systems serial numbers from 146352 to 147617

    Distribution

    Nationwide Distribution.

    Quantity

    284