BEUDAMED
    FDA Enforcement Class II Terminated

    Cable remote control JUC, BUTTON, Material no.1239823, Serial number: to (incl.) 100143048. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.

    Recall: Z-0928-2015 · Reported January 14, 2015

    Enforcement

    Recall Number
    Z-0928-2015
    Event ID
    69927
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Trumpf Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 14, 2015
    Initiation Date
    December 3, 2014
    Classification Date
    January 6, 2015
    Termination Date
    August 23, 2016
    Address
    1046 Legrand Blvd, N/A, Charleston, SC, 29492-7672, United States

    Description

    Cable remote control JUC, BUTTON, Material no.1239823, Serial number: to (incl.) 100143048. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.

    Reason

    Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes

    Code Info

    The operating tables which are operated with the affected remote controls (all serial numbers): Mobile column JUPITER System U, Material no. 4500113; Mobile column JUPITER System Miyabi U, Material no. 1574977; Operating table column JUPITER SM 360 U, Material no. 1389824; Operating table column JUPITER SF U OCE, Material no. 1622774; Stationary column JUPITER System U, Material no. 4500112; FLOOR MOUNTING COLUMN JUPITER U, Material no. 1276277; Floor mounting column JUPITER 360 U, Material no.1389826; Operating table JUPITER UNIVERSAL U, Material no. 4500170; OR-TABLE JUPITER UNIVERSAL CARBON U, Material no.1223188.

    Distribution

    Worldwide Distribution - USA including AL, AZ, CA, CT, FL, GA, IL, KS, LA, MD, MI, MK, MS, NC, NH, NJ, NY, OH, OK, PA, RI, SC, TX, VA, WA, WI and Internationally to Canada.

    Quantity

    3303 total all devices