BEUDAMED
    FDA Recall Terminated

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment.

    Recall: Z-2586-2014 · Initiated July 2, 2014

    Recall

    Recall Number
    Z-2586-2014
    Event Number
    69125
    Firm
    Spacelabs Healthcare Inc
    FEI Number
    3010157426
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 2, 2014
    Posted
    September 4, 2014
    Terminated
    October 16, 2014
    Address
    35301 SE Center St, Snoqualmie, WA, 98065-9216

    Description

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment.

    Reason

    The transmitter display and the Telemetry Central Station display may show a SpO2 value when the sensor is not connected to the patient or in certain sensor failed conditions. This is an expansion of recall Z-0871-2014 because additional serial numbers were identified as being part of this recall action as part of the firm's retrospective analysis of all recalls since 2011.

    Action

    Spacelabs notified both consignees via email of the expanded recall July 2, 2014. A f/u letter was sent by overnight delivery to the single new consignee the same day. Spacelabs sent an announcement of the expanded recall to both consignees identified in the expanded recall August 25, 2014. A field service technician from Spacelabs will visit each consignee and upgrade the software as necessary. If you have any questions about this corrective action program, please contact SpaceLabs Healthcare at 1-800- 522-7025, and select 2 for Technical Support.

    Distribution

    US Distribution to TX.

    Quantity

    8 units