Events

Recall of Device Recall Transonic Flow Probe

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Transonic Systems Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71907
  • Event Risk Class
    Class 2
  • Event Number
    Z-2728-2015
  • Event Initiated Date
    2015-07-27
  • Event Date Posted
    2015-09-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-07-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139366
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Flowmeter, blood, cardiovascular - Product Code DPW
  • 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.

Device

Device Recall Transonic Flow Probe
  • Model / Serial
    Serial Numbers: HQD4FMC3504, HQD4FMC3505, HQD4FMC3506, HQD4FMC3507, HQD4FMC3508, HQD4FMC3509, HQD4FMC3510, HQD4FMC3511, HQD4FMC3512, HQD4FMC3513, HQD4FMC3514, HQD4FMC3515, HQD4FMC3516, HQD4FMC3517, HQD4FMC3518, HQD4FMC3519, HQD4FMC3520
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands.
  • Product Description
    Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: || to measure flow intra-operatively.
  • Manufacturer
    Transonic Systems Inc

Manufacturer

Transonic Systems Inc
  • Manufacturer Address
    Transonic Systems Inc, 34 Dutch Mill Rd, Ithaca NY 14850-9785
  • Manufacturer Parent Company (2017)
    Measurement Innovations Corp
  • Source
    USFDA