Events

Recall of Device Recall Transonic Hemodialysis Monitor

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
    70647
  • Event Risk Class
    Class 2
  • Event Number
    Z-1295-2015
  • Event Initiated Date
    2015-02-17
  • Event Date Posted
    2015-03-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134239
  • 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
    System, hemodialysis, access recirculation monitoring - Product Code MQS
  • Reason
    Customer unable to obtain measurements due to the device seeing no flow or irrelevant flow condition during dialysis procedures. the user saw a zero or a very low flow value displayed on hd03 and/or no measurements produced in other modes (recirculation; access flow; or cardiac output).
  • Action
    Transonic sent a Medical Device Recall Letters and Response Forms dated February 17, 2015 to the users via e-mail and fax. The recall is being conducted to the user level. The letter identified the affected product, problem and actions to be taken. For questions call 607-257-5300 ext. 326.

Device

Device Recall Transonic Hemodialysis Monitor
  • Model / Serial
    Serial Numbers HD03A60004; HD03A81167; HD03A81225; HD03A81237; HD03A91338; HD03A91394; HD03A91406; HD03B01461; HD03B21782; HD03B21803; HD03A60020; HD03A71082; HD03A81207; HD03A91255; HD03A91316; HD03Bl1679; HD03B11684; HD03B11705; HD03B21812; HD03B31971; HD03A81240; HD03A71086; HD03B01459; HD03B01594; HD03B11667; HD03B42175; HD03B42160; HD03B42161; HD03A91258; HD03A70046; HD03B31901
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide and the countries of: Australia, Canada, and South Korea
  • Product Description
    Transonic Hemodialysis Monitor, Model HD03 -- || Product Usage: The Hemodialysis Monitor is intended for use by trained medical personnel to measure delivered blood flow, vascular access recirculation, vascular access blood flow and cardiac output on patients receiving hemodialysis treatment.
  • Manufacturer
    Transonic Systems Inc

Manufacturer

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