BEUDAMED
    FDA Recall Terminated

    Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System

    Recall: Z-1112-2013 · Initiated March 6, 2013

    Recall

    Recall Number
    Z-1112-2013
    Event Number
    64653
    Firm
    Carefusion Corporation
    FEI Number
    3003879246
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 6, 2013
    Posted
    April 15, 2013
    Terminated
    May 8, 2014
    Address
    3750 Torrey View Ct, San Diego, CA, 92130-2622

    Description

    Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System

    Reason

    The recall was initiated because Carefusion has identified potential risk associated with bolus programming with the Alaris PC unit (model 8015) software version 9.12. Automating infusion pump parameter input from either the electronic medical record (EMR) or the Alaris Auto-ID module for a continuous infusion with a bolus dose option may result in a loss of information from the Guardrails Data s

    Action

    Carefusion sent an Urgent Medical Device Recall Notification letter dated March 6, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers are required to confirm receipt of the notification by returning the Recall response card to Carefusion by postage-paid, self-addressed mail, fax, or email. The letter stated that a Carefusion representatives will contact customers by telephone to schedule field remediation. For questions call Carefusion Support Center at 888-562-6018, Customer Advocacy at 888-812-3266, and/or Technical Support at 888-812-3229.

    Distribution

    Worldwide Distribution USA Nationwide and the countries of Australia and Canada.

    Quantity

    4,090 total units