BEUDAMED
    6 results · 69ms · Sources: EU EUDAMED, US FDA

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    PATIENT POSITIONING SYSTEM

    FDA Adverse Event
    Malfunction ·FORTE AUTOMATION SYSTEMS, INC·Product code JAI·August 17, 2017

    Patient Positioning System with KRC2 controller using software versions 2.3.1 2.3.10 Product Usage: The patient positioning system is a SCARA designed robotic arm designed to position a patient for medical procedures prescribed by oncologists and others that require a high degree of accuracy and repeatability.

    FDA Recall
    Terminated ·Forte Automation Systems Inc·Product code JAI·September 5, 2017

    Patient Positioning System with KRC2 controller using software versions 2.3.1 2.3.10 Product Usage: The patient positioning system is a SCARA designed robotic arm designed to position a patient for medical procedures prescribed by oncologists and others that require a high degree of accuracy and repeatability.

    FDA Enforcement
    Class II ·Terminated·Forte Automation Systems Inc·August 1, 2018

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·October 26, 2010

    SUNGO Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·1571 Manufacturers·20390 Devices

    Advena Limited

    Authorized representative
    🇲🇹 Malta·467 Manufacturers·13717 Devices