BEUDAMED
    FDA Enforcement Class II Ongoing

    ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging

    Recall: Z-3248-2018 · Reported October 3, 2018

    Enforcement

    Recall Number
    Z-3248-2018
    Event ID
    81045
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Swissray Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 3, 2018
    Initiation Date
    August 9, 2016
    Classification Date
    September 25, 2018
    Address
    Hohenrainstrasse 61, Hochdorf, N/A, Switzerland

    Description

    ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging

    Reason

    Possible injury due to movement of the arm, calibration loss and communication loss.

    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, 1702001, 1702002, 1702003 & 1702004

    Distribution

    US Nationwide

    Quantity

    26 units