BEUDAMED
    FDA Recall Terminated

    Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to measure flow intra-operatively.

    Recall: Z-2726-2015 · Initiated July 27, 2015

    Recall

    Recall Number
    Z-2726-2015
    Event Number
    71907
    Firm
    Transonic Systems Inc
    FEI Number
    1319030
    Product Code
    DPW
    Status
    Terminated
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    July 27, 2015
    Posted
    September 3, 2015
    Terminated
    July 18, 2016
    Address
    34 Dutch Mill Rd, Ithaca, NY, 14850-9785

    Description

    Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- 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.

    Action

    Transonic sent an Urgent Medical Device Recall letters and Response Forms dated July 27, 2015 to customers via Certified Mail, email and/or fax. The letter identified the affected product, problem and actions to be taken. Customers are instructed to contact Transonic Systems' Customer Service at 1-800-353-3569 or 1-607-257-5300 to arrange for replacement (repair/exchange) immediately.

    Distribution

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

    Quantity

    Domestic: 8 units, foreign: 11 units