Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Olympus Medical Systems Corporation, QIL FY24-EMEA-40-FY24-OMSC-36, Single Use Electrosurgical Knife

   Olympus's investigation has identified that deterioration of the cutting knife can contribute to tip breakage during use. ...

   Waarschuwing | 14-03-2024

2. Quanta System SpA FSCA-02-2021 - Optical Fiber

   Deze veiligheidswaarschuwing maakt onderdeel uit van een groter Europees onderzoek naar vervalste certificaten. Doordat de ...

   Waarschuwing | 16-04-2021

3. ConvaTec Limited, FSN-FSCA 2020-001, Aquacel Ag Hydrofiber Dressing with silver

   ConvaTec initieert vrijwillig een veldactie voor de Aquacel Ag Hydrofiber Dressing with silver, omdat in sommige gevallen is ...

   Waarschuwing | 05-05-2021

4. SenoRx-VT-RAP-19-02-001-EnCor Breast Biopsy

   Op basis van feedback van klanten heeft BD vastgesteld dat de in bijlage 1 genoemde productcodes/lotnummers kunnen lekken op de ...

   Waarschuwing | 01-05-2019

5. Richard Wolf GmbH, FSN-QM700017105, HF SURGERY GENERATOR 400KHZ

   In rare cases, using the auto-start and / or auto stop function may lead to device error 0233, which causes the HF current to be ...

   Waarschuwing | 27-01-2022

6. Howmedica Osteonics Corp, RA2019-2197654, X-Change

   Stryker has discovered that certain boxes of the 6-Petal X-Change Wall Mesh Small (Part # 0942-8-025) contain the 4-Petal ...

   Waarschuwing | 28-11-2019

7. Megadyne Medical Products, Inc., 2370372, MEGADYNE™ MEGA SOFT™ and MEGA 2000™ Reusable Patient Return Electrodes

   Megadyne Medical Products, Inc. (“Megadyne”) has received reports of patient burns identified after surgical procedures in which ...

   Waarschuwing | 24-06-2024

8. Megadyne Medical Products, Inc., 2334283 - MEGA SOFT Patient Return Electrodes, MEGADYNE™ MEGA SOFT™ UNIVERSAL AND UNIVERSAL PLUS REUSABLE PATIENT RETURN ELECTRODES

   Megadyne Medical Products, Inc. (“Megadyne”) has received reports of patient burns identified after surgical procedures in which ...

   Waarschuwing | 18-01-2024

9. Beaver Visitec International LTD., FSN-FA-22-008, BVI CustomEyes Packs

   De BVI CustomEyes® verpakkingen van instrumenten, ook bekend als de BVI verpakkingen voor instrumenten voor oogchirurgische ...

   Waarschuwing | 09-03-2023

10. Integra LifeSciences (Ireland) Limited, 2024-HHE-006, Cusa Excel 23kHz Straight Handpiece

    The decision to conduct a voluntary correction of the product was based on the following: through an internal investigation of ...

    Waarschuwing | 03-06-2024