BEUDAMED
    FDA Enforcement Class II Terminated

    Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and Alarm. The Multi-parameter Module is used with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from a patient in a clinical environment.

    Recall: Z-1705-2014 · Reported June 11, 2014

    Enforcement

    Recall Number
    Z-1705-2014
    Event ID
    68357
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Spacelabs Healthcare Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    June 11, 2014
    Initiation Date
    May 8, 2014
    Classification Date
    June 3, 2014
    Termination Date
    June 3, 2014
    Address
    35301 SE Center St, Snoqualmie, WA, 98065-9216, United States

    Description

    Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and Alarm. The Multi-parameter Module is used with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from a patient in a clinical environment.

    Reason

    A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms.

    Code Info

    All devices of Model: 91496.

    Distribution

    US Distribution to GA.

    Quantity

    64 devices