Device product
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.
Z-2775-2016
Product summary
- Event
- Event 74837
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 (5 in Us distribuion and 1 in Japan)
- Official record key
device-enforcement:Z-2775-2016
Official wording
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.
Code information: TQH-MD-E0101, THQ-MD-E-0102, TQH-MD-E0103, TQH-MD-E0104, TQH-MD-EMP003, TQH-MD-EMP-002.
Distribution pattern: Worldwide distribution - US including FL, NY and Internationally to Japan.
Derived failure modes
-
Device software or design
software versions 1.0 and 1.0 SP! have a software defect