FDA Medical Device Recalls (openFDA)
Thermo Finnigan LLC: 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.
- Recall number
- Z-2775-2016
- 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.
- Status
- Terminated
- Initiated
- 2016-07-19
- Posted
- 2016-09-09
- Terminated
- 2017-02-21
- 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.
- 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 FieldActionTeam@thermofisher.com. Customers with questions should contact the Field Action Team at FieldAction@thermofisher.com.
- Quantity
- 6 (5 in Us distribuion and 1 in Japan)
- Distribution
- Worldwide distribution - US including FL, NY and Internationally to Japan.
- Lot, serial or model codes
- TQH-MD-E0101, THQ-MD-E-0102, TQH-MD-E0103, TQH-MD-E0104, TQH-MD-EMP003, TQH-MD-EMP-002.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DOP
- Firm FEI
- 3003809634
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28