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Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

46 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. Amann Girrbach AG, FSN-CAPA Nr.62, Ceramill Zolid FX ML

    Amann Girrbach AG want to inform you about the possibility of a contamination of the blanks in the batches of Zolid FX Multilayer ...

    Waarschuwing | 20-05-2021

  2. XO CARE A/S MLHN-AEWDNP-FSCA - Dental units XO 4 and XO FLEX

    The suction hoses for the XO Units, containing magnets, have the potential to negatively impact implanted pacemakers and ...

    Waarschuwing | 23-01-2018

  3. Align Technology FAB-12570 - Invisalign system aligners

    Due to a software issue in some of the stages the attachment position in the aligner was inadvertently shifted toward the ...

    Waarschuwing | 09-08-2021

  4. Nobel Biocare, PFA1906, drills etc

    Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the ...

    Waarschuwing | 27-03-2019

  5. Geistlich Pharma AG, FSN-2020-10-09, Geistlich Bio-Oss Pen

    Recall of Geistlich Bio-Oss Pen® due to functional issue.

    Waarschuwing | 09-10-2020

  6. NOUVAG AG, FSN-C11607, MD11 / MD30

    The devices MD 11 and MD 30 do not comply with the latest harmonized EMC standard (60601-1-2, Edition 4).

    Waarschuwing | 14-08-2020

  7. Skulle Implants FSN0719 - GLACE Screws 6 mm

    Skulle Implants Corporation is conducting a medical device Field Safety Corrective Action for the GLACETM CMF 6 mm screws due to ...

    Waarschuwing | 08-07-2019

  8. Zimmer Dental RN15-003 NL - Trabecular Metal Dental Implant

    Through investigation, Zimmer Dental determined that information specific to the 3.7mmD and 4.1mmD Trabecular Metal implants was ...

    Waarschuwing | 08-01-2016

  9. Dentsply Sirona_Maillefer Instruments HHE 2020-1 - Finger Spreaders

    During a domestic inspection, Dentsply Sirona has detected a sporadic dimensional issue on a production of Finger Spreaders D ...

    Waarschuwing | 28-02-2020

  10. 3M Company, FSN-2021-09 Lingual Wire, 3M™ Lingual Retainer Wire

    Tijdens een recent kwaliteitsonderzoek heeft 3M ontdekt dat deze partijen linguale beugeldraden een onjuiste stap in het ...

    Waarschuwing | 19-10-2021

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