BEUDAMED
    FDA Enforcement Class II Ongoing

    ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging

    Recall: Z-3191-2018 · Reported September 26, 2018

    Enforcement

    Recall Number
    Z-3191-2018
    Event ID
    80981
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Swissray Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 26, 2018
    Initiation Date
    November 18, 2016
    Classification Date
    September 18, 2018
    Address
    Hohenrainstrasse 61, N/A, Hochdorf, N/A, N/A, Switzerland

    Description

    ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging

    Reason

    Potential for bucky (the part that holds the grid and is moveable to position the patient) moving unexpectedly.

    Code Info

    Serial Numbers within U.S.A commerce - 1302002, 1302003, 1302005, 1302009, 1302011, 1402001, 1402002, 1402006, 1402007, 1402008, 1402009, 1402011, 1402012, 1402015, 1502001, 1502002, 1502004, 1502005, 1502006, 1502007, 1602001, 1602002, 1602003, 1602005, 1602006, 1602007 & 1602008 Serial Numbers Outside of U.S.A commerce - 1402005, 1402017, 1502009, 1502010, 1502011, 1302004, 1302006, 1302007, 1302008, 1302010, 1402003, 1402004, 1402010, 1402013, 1402014, 1402016, 1502008 & 1602004

    Distribution

    Worldwide Distribution: US (Nationwide) and to countries of: Austria, Dubai, China. Germany, Libya, Malaysia, Russia, and South Africa.

    Quantity

    27 devices in US