Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Beaver Visitec International Inc., FSN-FA-22-005, Beaver®Artho-LOK Pointed Tip Curve L 4mm Blade

   BVI has received two complaints from customers that two lots of Catalog # 376780, Beaver®Artho-LOK Pointed Tip Curve L 4mm Blades ...

   Waarschuwing | 19-10-2022

2. Medtronic, FA1247, NIM Vital Nerve Monitoring System

   Failure to connect the ground electrode during case setup will incorrectly display a false passing ground impedance /electrode ...

   Waarschuwing | 17-06-2022

3. Brightwake Limited BW001-25 - Algivon Honey Dressing and Activon Tube

   Brightwake’s Algivon Honey Dressing and Activon Tube products were stolen when in transit to be sterilised. Both products are ...

   Waarschuwing | 27-05-2021

4. Medtronic, FA1324, Neuroscience CST StealthStation S7 Cranial Software v3.1.4

   Medtronic identified two software anomalies in StealthStation™ Cranial Version 3.1.4 software that can occur under specific ...

   Waarschuwing | 21-12-2023

5. PAUL HARTMANN AG, FSN-10001017624, Tela® products, Longuetten and corresponding procedure trays (CombiSet®)

   The listed Tela® products and Longuetten are gauze products containing an interwoven x-ray detectable thread. The listed ...

   Waarschuwing | 01-09-2020

6. Paul Hartmann 10001017624 - Tela® products, Longuetten, and procedure trays (CombiSet®)

   Due to feedback from clinics and the information of the supplier of our x-ray products we learned that the x-ray thread of the ...

   Waarschuwing | 01-09-2020

7. Field Safety Notice: Optimed - sinus-SuperFlex-635

   The details of the label on the packaging do not correspond to the delivered product. The information of the inner label on the ...

   Waarschuwing | 31-03-2017

8. Gyrus ACMI, Inc. (Olympus Surgical Technologies America), QIL FY24-EMEA-32-FY24-OSTA-12, SOLTIVE Single-use Laser Fibers

   Olympus conducted an internal review of the SOLTIVE Single-use Fibers and identified inconsistencies in the IFU. Olympus is ...

   Waarschuwing | 14-12-2023

9. Intuitive Surgical, Inc., ISIFA2022-14-C Expansion, a Vinci Xi and da Vinci X Surgical System

   This Field Safety Notice is to notify you that a population of the da Vinci X and Xi system instrument arms (USMs) have ...

   Waarschuwing | 13-11-2023

10. ARB Medical_Medpace - Rebound HRD and HRD-V

    This FSCA/recall is due to complaints of the fracture of the frame (ring) of the product (which is implanted to repair hernias) ...

    Waarschuwing | 04-10-2018