BEUDAMED
    FDA Recall Terminated

    Ambulatory Blood Pressure (ABP) Monitor, Model 90217A. The Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor is a small, lightweight unit designed to take blood pressure and heart rate measurements for a 24 hour, 48 hour, or longer period.

    Recall: Z-0304-2012 · Initiated October 12, 2011

    Recall

    Recall Number
    Z-0304-2012
    Event Number
    60204
    Firm
    Del Mar Reynolds Medical, Ltd. 1-2 Harforde Ct., Foxholes Business Park Hertford United Kingdom
    FEI Number
    3002807992
    Product Code
    DXN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 12, 2011
    Posted
    November 29, 2011
    Terminated
    May 30, 2012

    Description

    Ambulatory Blood Pressure (ABP) Monitor, Model 90217A. The Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor is a small, lightweight unit designed to take blood pressure and heart rate measurements for a 24 hour, 48 hour, or longer period.

    Reason

    If external pressure is applied to the cuff of the Ambulatory Blood Pressure, Model 90217A, during deflation, the monitor will stop working and display an EC75 error code.

    Action

    On October 21, 2011, a Medial Device Correction customer letter was mailed to all US customers. A return receipt was requested. The letter identified the affected devices and described the problem. If the device displays an EC75 error code, customers can cycle the power off and then on to restore normal functionality. Please advise patients of this mitigation to avoid a delay in obtaining results. The firm is in the process of upgrading their software to avoid the issue and will contact customers to arrange for an update to their monitors. Customers can call Spacelabs Healthcare at 1-800-522-7025, select 2 for Technical support for any question about this recall.

    Distribution

    Worldwide Distribution

    Quantity

    785 units worldwide (83 in US and 702 outside US)