Events

Recall of Device Recall Thermo Finnigan ENDURA MD Mass Spectrometer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Thermo Finnigan LLC.

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
    74837
  • Event Risk Class
    Class 2
  • Event Number
    Z-2775-2016
  • Event Initiated Date
    2016-07-19
  • Event Date Posted
    2016-09-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148564
  • 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
    Mass spectrometer, clinical use - Product Code DOP
  • Reason
    Thermo fisher has determined that the endura md mass spectrometer instrument control software versions 1.0 and 1.0 sp! have a software defect which affect data accuracy.
  • Action
    ThermoFisher Scientific sent an Urgent Medical Device Field Correction letter dated July 19, 2016, to all affected customers via FedEx. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to discontinue use of the affected product until a company authorized Field Service Engineer installs corrected software to the instrument system. Customers were also instructed to communicate to all who operate the instrument and to complete the provided Acknowledgment Form, sign, and return it via email FieldActionTeam@thermofisher.com. Customers with questions should contact the Field Action Team at FieldAction@thermofisher.com.

Device

Device Recall Thermo Finnigan ENDURA MD Mass Spectrometer
  • Model / Serial
    TQH-MD-E0101, THQ-MD-E-0102, TQH-MD-E0103, TQH-MD-E0104, TQH-MD-EMP003, TQH-MD-EMP-002.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution - US including FL, NY and Internationally to Japan.
  • Product Description
    Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1. || In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body. || Chemistry: In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body.
  • Manufacturer
    Thermo Finnigan LLC

Manufacturer

Thermo Finnigan LLC
  • Manufacturer Address
    Thermo Finnigan LLC, 355 River Oaks Pkwy, San Jose CA 95134-1908
  • Manufacturer Parent Company (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA