BEUDAMED
    FDA Recall Terminated

    Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm priority (i.e. high, medium or low); (c) alarm limits; and (d) when to generate and terminate alarms. PCIS patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Medical PCIS patient monitors are designed to communicate with a variety of external devices such as display devices, network devices, serial devices, user input devices, audio system, local/remote recorders and Spacelabs Medical patient parameter modules. In all applications, Spacelabs Medical PCIS patient monitors provide access to that data on the Spacelabs Medical network either via hardwire or wireless transmission. Through this network, a patient's data may be displayed at the bedside monitor, central station or clinical information system.

    Recall: Z-2382-2012 · Initiated August 27, 2012

    Recall

    Recall Number
    Z-2382-2012
    Event Number
    63007
    Firm
    Spacelabs Healthcare, Llc
    FEI Number
    3010157426
    Product Code
    DSI
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    August 27, 2012
    Posted
    September 14, 2012
    Terminated
    April 15, 2013
    Address
    5150 220th Ave Se, Issaquah, WA, 98029-6834

    Description

    Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm priority (i.e. high, medium or low); (c) alarm limits; and (d) when to generate and terminate alarms. PCIS patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Medical PCIS patient monitors are designed to communicate with a variety of external devices such as display devices, network devices, serial devices, user input devices, audio system, local/remote recorders and Spacelabs Medical patient parameter modules. In all applications, Spacelabs Medical PCIS patient monitors provide access to that data on the Spacelabs Medical network either via hardwire or wireless transmission. Through this network, a patient's data may be displayed at the bedside monitor, central station or clinical information system.

    Reason

    There is a potential failure of the Integrated Module Housing causing the patient module parameters to drop off the monitor display or the patient module will fail to sign on when inserted into the housing.

    Action

    Spacelabs Healthcare sent an "URGENT- MEDICAL DEVICE CORRECTION" letter dated August 27, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 1-800-522-7025 and select 2 for assistance regarding this recall.

    Distribution

    Worldwide Distribution.

    Quantity

    527 units total; 350 US and 177 International