BEUDAMED
    FDA Enforcement Class II Terminated

    Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow intra-operatively.

    Recall: Z-2723-2015 · Reported September 9, 2015

    Enforcement

    Recall Number
    Z-2723-2015
    Event ID
    71907
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Transonic Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 9, 2015
    Initiation Date
    July 27, 2015
    Classification Date
    September 2, 2015
    Termination Date
    July 18, 2016
    Address
    34 Dutch Mill Rd, N/A, Ithaca, NY, 14850-9785, United States

    Description

    Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow intra-operatively.

    Reason

    Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number.

    Code Info

    Serial Numbers: HQC8FMV2142, HQC8FMV2143, HQC8FMV2144, HQC8FMV2145, HQC8FMV2146

    Distribution

    Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands.

    Quantity

    Domestic: 5 units