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Recall Observatory FDA recall evidence

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

July 19, 2016

Class II

Product summary

Firm
Thermo Finnigan LLC
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

    reason.device_software_design · v1.0.0

    software versions 1.0 and 1.0 SP! have a software defect