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.

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.

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 [email protected]. Customers with questions should contact the Field Action Team at [email protected].