BEUDAMED
    FDA Enforcement Class II Terminated

    Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measure flow intra-operatively.

    Recall: Z-2727-2015 · Reported September 9, 2015

    Enforcement

    Recall Number
    Z-2727-2015
    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 HQD3FMC -- 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: HQD3FMC3763, HQD3FMC3764, HQD3FMC3765, HQD3FMC3766, HQD3FMC3767, HQD3FMC3768, HQD3FMC3769, HQD3FMC3770, HQD3FMC3771, HQD3FMC3772, HQD3FMC3773, HQD3FMC3774, HQD3FMC3775, HQD3FMC3776, HQD3FMC3777, HQD3FMC3778, HQD3FMC3779, HQD3FMC3780, HQD3FMC3781, HQD3FMC3782, HQD3FMC3783, HQD3FMC3784, HQD3FMC3785, HQD3FMC3786, HQD3FMC3787, HQD3FMC3788, HQD3FMC3789, HQD3FMC3790, HQD3FMC3791, HQD3FMC3792, HQD3FMC3793, HQD3FMC3794, HQD3FMC3795, HQD3FMC3796, HQD3FMC3797, HQD3FMC3798, HQD3FMC3799, HQD3FMC3800, HQD3FMC3801, HQD3FMC3802, HQD3FMC3803, HQD3FMC3804, HQD3FMC3805, HQD3FMC3806, HQD3FMC3807, HQD3FMC3814, HQD3FMC3815

    Distribution

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

    Quantity

    Domestic: 35 units, Foreign: 12 units