Endura MD Mass Spectrometer u using software versions Endura MD… — Class II medical device recall Z-2775-2016
Terminated recall by Thermo Finnigan LLC, reported 2016-09-21, distributed in FL, NY. Thermo Fisher has determined that the Endura MD mass spectrometer instrument control software versions 1.0 and
| Recall number | Z-2775-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Thermo Finnigan LLC, San Jose, CA, United States |
| Recall initiated | 2016-07-19 |
| Classified | 2016-09-09 |
| Reported by FDA | 2016-09-21 |
| Terminated | 2017-02-21 |
| Distributed | FL, NY |
| Countries outside the US | JP |
| Quantity | 6 |
| Reason classes | software |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2775-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.