BEUDAMED
    FDA Recall Terminated

    CareSuite" - Critical Care Manager, PACU Manager and Anesthesia Manager Software: CareSuite 5.1 and later

    Recall: Z-1252-2010 · Initiated March 8, 2010

    Recall

    Recall Number
    Z-1252-2010
    Event Number
    54934
    Firm
    Picis Inc.
    FEI Number
    3005244943
    Product Code
    NSX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 8, 2010
    Posted
    April 6, 2010
    Terminated
    July 1, 2013
    Address
    100 Quannapowitt Parkway, Suite 405, Wakefield, MA, 01880

    Description

    CareSuite" - Critical Care Manager, PACU Manager and Anesthesia Manager Software: CareSuite 5.1 and later

    Reason

    Under specific timing of conditions and in configuration with 3rd party infusion pumps, an error within the clinical application causes the manual documentation of clinical orders to be changed to an automatic update status. At this point, the order documentation becomes frozen at the last dose and/or rate and the user is unable to modify, stop or delete it. This error could impact the fluid bala

    Action

    Picis issued letter notification beginning on March 8, 2010 with software correction information. The letter communicates details of the problem, along with recommendations for mitigating the potential to experience this error condition. Use of the product should be discontinued until the update described in the letter is performed. Customers with questions should call the company at 781-557-3000.

    Distribution

    NJ Canada, Australia, Austria,Denmark, Finland, Germany Norway,Portugal, Sweden, France,Netherlands, Spain.

    Quantity

    23