BEUDAMED
    FDA Recall Terminated

    PICIS, CareSuite Family- OR Manager (4235), Preop Manager (4250), Anesthesia Manager (4220), PACU Manager (4245) & Critical Care Manager (1110), patient information systems.

    Recall: Z-0365-2010 · Initiated April 8, 2009

    Recall

    Recall Number
    Z-0365-2010
    Event Number
    51876
    Firm
    Picis Inc.
    FEI Number
    3005244943
    Product Code
    NSX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 8, 2009
    Posted
    November 18, 2009
    Terminated
    December 22, 2014
    Address
    100 Quannapowitt Parkway, Suite 405, Wakefield, MA, 01880

    Description

    PICIS, CareSuite Family- OR Manager (4235), Preop Manager (4250), Anesthesia Manager (4220), PACU Manager (4245) & Critical Care Manager (1110), patient information systems.

    Reason

    Demographic data, most notably allergy and precaution data, can be overwritten with incomplete data or blanks by the interface between non-Picis clinical systems (your "HIS" or "CIS") and certain Picis applications, if that interface is not configured properly.

    Action

    On April 8th 2009, Picis initiated a customer notification letter to the installed base of potentially affected users, explaining the potential source of patient data conflict and to provide support in choosing the appropriate configuration option and implementation. The notification letters included with this report package contain additional details regarding configuration options.

    Distribution

    Worldwide distribution: USA, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Italy, Malaysia, Netherlands, Norway, Portugal, Singapore, Spain, Sweden, and United Kingdom

    Quantity

    325