BEUDAMED
    FDA Enforcement Class II Terminated

    Responder 5 is a nurse call communication system that connects patients with staff in a hospital. The nurse call system also connects team members and departments from radiology, physical therapy, transport, environmental services and more. Responder 5 is used in hospitals and long term patient care facilities to allow for remote communications between patients and patient monitoring devices and healthcare providers

    Recall: Z-2213-2013 · Reported September 25, 2013

    Enforcement

    Recall Number
    Z-2213-2013
    Event ID
    65657
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Rauland-Borg Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 25, 2013
    Initiation Date
    May 10, 2013
    Classification Date
    September 17, 2013
    Termination Date
    May 6, 2015
    Address
    1802 W Central Rd, N/A, Mount Prospect, IL, 60056-2230, United States

    Description

    Responder 5 is a nurse call communication system that connects patients with staff in a hospital. The nurse call system also connects team members and departments from radiology, physical therapy, transport, environmental services and more. Responder 5 is used in hospitals and long term patient care facilities to allow for remote communications between patients and patient monitoring devices and healthcare providers

    Reason

    A counterfeited electronic component was identified in the products affected. The component, a data transceiver (transmitter/receiver), is associated with the intercommunication of these devices in the Responder 5 system across the L-Net data path. Failure of a data transceiver results in the loss of nurse call functionality in the associated room, and may disrupt communications on the L-Net run

    Code Info

    1) Product Code 351000 (Branch Regional Controller); 2) Product Code 352000 (Corridor Light); 3) Product Code 352020 (Domeless Controller)

    Distribution

    Worldwide distribution - US: (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NE, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI and WV., and the countries of : Australia, Canada, Columbia, Lebanon, Mexico and Saudi Arabia.

    Quantity

    Product Code 351000: 385 units; Product Codes 352000 and 352020: 14,808 units (total)