BEUDAMED
    FDA Enforcement Class II Terminated

    Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to measure flow intra-operatively.

    Recall: Z-2721-2015 · Reported September 9, 2015

    Enforcement

    Recall Number
    Z-2721-2015
    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, 3 mm, Catalog Number HQC3FMC -- 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: HQC3FMC2501, HQC3FMC2502, HQC3FMC2503, HQC3FMC2504, HQC3FMC2505, HQC3FMC2506, HQC3FMC2507, HQC3FMC2508, HQC3FMC2509, HQC3FMC2510, HQC3FMC2511, HQC3FMC2512, HQC3FMC2513, HQC3FMC2514, HQC3FMC2515, HQC3FMC2516, HQC3FMC2517, HQC3FMC2518, HQC3FMC2519, HQC3FMC2520, HQC3FMC2521, HQC3FMC2522, HQC3FMC2523, HQC3FMC2524, HQC3FMC2525, HQC3FMC2526, HQC3FMC2527, HQC3FMC2528, HQC3FMC2529, HQC3FMC2530, HQC3FMC2531, HQC3FMC2532, HQC3FMC2533, HQC3FMC2534, HQC3FMC2535, HQC3FMC2636

    Distribution

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

    Quantity

    Domestic: 36 units