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-1098-2013 · Initiated March 6, 2013

    Recall

    Recall Number
    Z-1098-2013
    Event Number
    64728
    Firm
    Carefusion Corporation
    FEI Number
    3003879246
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 6, 2013
    Posted
    April 15, 2013
    Terminated
    September 2, 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 received reports of a communication error on the Alaris PC unit model 8015 with software version 9.12 when the Alaris EtCO2 module or Alaris SpO2 module is attached.

    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 action 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. Carefusion representatives will contact customers by telephone to schedule field remediation. For questions contact 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 China.

    Quantity

    9,241 units