BEUDAMED
    FDA Enforcement Class II Terminated

    Ziehm Imaging solo FD Mobile Fluoroscopic C-arm

    Recall: Z-1893-2017 · Reported May 24, 2017

    Enforcement

    Recall Number
    Z-1893-2017
    Event ID
    77030
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ziehm Imaging Inc
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    May 24, 2017
    Initiation Date
    February 23, 2017
    Classification Date
    May 16, 2017
    Termination Date
    December 11, 2019
    Address
    6280 Hazeltine National Dr Ste 100, Orlando, FL, 32822-5114, United States

    Description

    Ziehm Imaging solo FD Mobile Fluoroscopic C-arm

    Reason

    During Ziehm Imaging GmbH FDA inspection, the label for the Collimator and X-ray Control panel was missing the manufacturer date as part of the identification for certified component

    Code Info

    S/N 52199, 52108

    Distribution

    US Distribution to the states of : FL and CA. No devices listed in this recall where distributed any foreign /military/government consignees from the U.S.A.

    Quantity

    US - 2 systems