Recall Z-2775-2016 ยท DOP Mass Spectrometer, Clinical Use
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.
| Date | Sep 9, 2016 (initiated Jul 19, 2016) |
| Status | Terminated |
| 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. Cu |
| Quantity | 6 (5 in Us distribuion and 1 in Japan) |
| Distribution | Worldwide distribution - US including FL, NY and Internationally to Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.