8 results
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24ms
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Sources: EU EUDAMED, US FDA
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Country: Netherlands
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Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
FDA Enforcement
Class II
·Terminated·Technomed Europe·September 21, 2022
Life Technologies Europe B.V.
Authorized representative
🇳🇱 Netherlands·6 Manufacturers·12 Devices
Thermo Fisher Diagnostics B.V.
Importer
🇳🇱 Netherlands·4 Manufacturers
Life Technologies Europe B.V.
Importer
🇳🇱 Netherlands·6 Manufacturers
Thermo Fisher Diagnostics B.V.
Authorized representative
🇳🇱 Netherlands·4 Manufacturers
There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron brachytherapy afterloader system. Due to an obstruction during the check cable out drive, the internal guiding tube became displaced and the check cable became damaged. This issue could cause treatment interruption or in a very unlikely scenario, incorrect source positioning and radiation treatment errors.
FDA Enforcement
Class II
·Terminated·Nucletron BV·January 8, 2020
BC Distribution B.V.
Importer
🇳🇱 Netherlands·13 Manufacturers
CEpartner4U
Authorized representative
🇳🇱 Netherlands·160 Manufacturers·5787 Devices