BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-2537-2018 · Reported August 1, 2018

    Enforcement

    Recall Number
    Z-2537-2018
    Event ID
    80510
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Forte Automation Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 1, 2018
    Initiation Date
    September 5, 2017
    Classification Date
    July 24, 2018
    Termination Date
    April 13, 2020
    Address
    8155 Burden Rd, N/A, Machesney Park, IL, 61115-8208, United States

    Description

    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.

    Reason

    Communications between the Patient Positioning System and the accuracy filter can periodically fail with no clear indication to the operator.

    Code Info

    PPS Serial Number Cabinet Type Software Version 7757-11 KRC2 2.3.3 7757-21 KRC2 2.3.3 7757-31 KRC2 2.3.3 7757-41 KRC2 2.3.3 7757-51 KRC2 2.3.8 7755-21 KRC2 2.3.3 7755-31 KRC2 2.3.3 7755-41 KRC2 2.3.3 7392-2 KRC2 2.3.3 7392-3 KRC2 2.3.3 7392-4 KRC2 2.3.3 7392-1 KRC2 2.3.8 7392-5 KRC2 2.3.8

    Distribution

    US in the state of California

    Quantity

    13