Z-2775-2016Class II

Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1. In vitro diagnostic...

Name: Z-2775-2016 Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1. In vitro diagnostic...
Creator: Thermo Finnigan LLC
Published: 2016-07-19
License: https://open.fda.gov/license/

Thermo Finnigan LLC / initiated 2016-07-19 / Terminated / root cause: software

FDA source

Thermo Finnigan LLC began a recall of 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... on 2016-07-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2775-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-19
Posted: 2016-09-09
Terminated: 2017-02-21
Recalling firm: Thermo Finnigan LLC
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.
Product code: DOP Mass Spectrometer, Clinical Use
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.
Root cause tag: software
FDA root cause: Software design
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 [email protected]. Customers with questions should contact the Field Action Team at [email protected].
Quantity in commerce: 6 (5 in Us distribuion and 1 in Japan)
Distribution: Worldwide distribution - US including FL, NY and Internationally to Japan.
Product codes and lots: TQH-MD-E0101, THQ-MD-E-0102, TQH-MD-E0103, TQH-MD-E0104, TQH-MD-EMP003, TQH-MD-EMP-002.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2775-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2775-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-09

Product code DOP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)