BEUDAMED
    FDA Recall Terminated

    Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile Prime ABG Analyzer with Scanner PN 52856 Stat Profile Prime CCS Analyzer PN 53656 Stat Profile Prime CCS Analyzer with Scanner PN 53657 Stat Profile Prime CCS Comp Analyzer with Scanner PN 52857 Stat Profile Prime CCS Comp Analyzer Blood Gas/Electrolyte/Metabolite/CO-Oximetry Analyzer

    Recall: Z-2732-2017 · Initiated June 19, 2017

    Recall

    Recall Number
    Z-2732-2017
    Event Number
    77532
    Firm
    Nova Biomedical Corporation
    FEI Number
    1219029
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 19, 2017
    Terminated
    August 14, 2018
    Address
    200 Prospect St, Waltham, MA, 02453-3457

    Description

    Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile Prime ABG Analyzer with Scanner PN 52856 Stat Profile Prime CCS Analyzer PN 53656 Stat Profile Prime CCS Analyzer with Scanner PN 53657 Stat Profile Prime CCS Comp Analyzer with Scanner PN 52857 Stat Profile Prime CCS Comp Analyzer Blood Gas/Electrolyte/Metabolite/CO-Oximetry Analyzer

    Reason

    Software- scheduled A-QC analysis could initiate prior to a patient result being released by the operator and result in the pending patient result being overwritten with the A-QC test results.

    Action

    Nova Biomedical issued Urgent Field Correction Notice on June 19, 2017, to all affected customers. The letter advises users of the problem and Nova Biomedical or an authorized Nova Biomedical representative will schedule a no charge update of your Stat Profile Prime Analyzer software to version VI1.0.883.0. A representative will contact customers to schedule this update. Questions: contact Nova Biomedical Technical Support at 1-800-545-6682, in Canada contact us at 1-800-263-5999, or outside of N. America contact your authorized Nova Biomedical subsidiary or distributor. For questions regarding this recall call 781-647-3700.

    Distribution

    Worldwide Distribution - US (Nationwide) Foreign: Albania Algeria Argentina Australia Austria Bangladesh Benin Bolivia Brazil Canada Chile China Colombia Costa Rica Czech Republic ECUADOR Egypt El Salvador Finland France Germany Ghana Greece Guatemala Guyana Honduras Hong Kong Hungary ICELAND India Iran Israel Italy Ivory Coast Japan Jordan Kenya Korea Latvia Macedonia Malaysia Mexico Nepal Netherlands Nigeria Pakistan Pakistan Palestine Peru Philippines Poland Puerto Rico Republic of Panama Republica Dominicana Russia Saudi Arabia Slovak Republic Slovenia South Africa Sri Lanka Switzerland Taiwan Thailand The Netherlands Trinidad,W.I. Tunisia Turkey UK Uruguay Vietnam

    Quantity

    179 units (US) and 904 (OUS) Total 1083