BEUDAMED
    FDA Recall Terminated

    i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E454448

    Recall: Z-0989-2017 · Initiated November 23, 2016

    Recall

    Recall Number
    Z-0989-2017
    Event Number
    76102
    Firm
    HEALTH ROBOTICS S.R.L. Via Sebastian Altmann 9 A 39100 Bolzano Italy
    FEI Number
    3006153342
    Product Code
    NEP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 23, 2016
    Posted
    January 10, 2017
    Terminated
    March 15, 2017

    Description

    i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E454448

    Reason

    The firm has initiated a product correction due to a bag carousel motor error causing misalignment and resulting in a mislabeling of final IV bag preparations.

    Action

    Omincell mailed an Urgent Medical Device Field Correction Notification letter to affected customers on 11/21/2016. The letter provided information of the event and instructions on how to continue operating the device to prevent risks. The issue will be corrected with a software update.

    Distribution

    Shipped throughout United States.

    Quantity

    121 systems