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U.S. Department of Health and Human Services

Class 2 Device Recall Thermo Finnigan ENDURA MD Mass Spectrometer

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  Class 2 Device Recall Thermo Finnigan ENDURA MD Mass Spectrometer see related information
Date Initiated by Firm July 19, 2016
Date Posted September 09, 2016
Recall Status1 Terminated 3 on February 21, 2017
Recall Number Z-2775-2016
Recall Event ID 74837
Product Classification Mass spectrometer, clinical use - Product Code DOP
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.
Code Information TQH-MD-E0101, THQ-MD-E-0102, TQH-MD-E0103, TQH-MD-E0104, TQH-MD-EMP003, TQH-MD-EMP-002.
Recalling Firm/
Manufacturer		 Thermo Finnigan LLC
355 River Oaks Pkwy
San Jose CA 95134-1908
For Additional Information Contact Renee Olson
408-965-6172
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 6 (5 in Us distribuion and 1 in Japan)
Distribution Worldwide distribution - US including FL, NY and Internationally to Japan.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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