Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. ALTATEC GmbH, 6189928, Knochenprofilfräser

   A physical examination of item number i5003.3350 revealed the sleeve is too tight to pass the profiler over the corresponding ...

   Waarschuwing | 02-11-2023

2. High Technology Products_Cocoon Medical MEDDEV2.12_HTP_02 - Cooltech

   Paradoxical adipose hyperplasia has been included in the latest version of the cooltech's User Manual with reference number ...

   Waarschuwing | 10-07-2019

3. VitreQ B.V., FSN-PRE-20210001, VitreQ

   Vitreq B.V. is issuing this Field Safety Notice to inform you about a potential issue that may affect CryoTreq, a disposable ...

   Waarschuwing | 19-04-2021

4. Arthrex INC, R537_NL, Knee Scorpion™

   Associated outer labels and label content document for indicated batches display a sterility statement indicating “sterile” via ...

   Waarschuwing | 17-08-2023

5. BALT EXTRUSION, FSN-20210224_SILKVista Baby_Missing Spring, SILK Vista Baby

   In het kader van zijn programma van post-marketing surveillance heeft BALT Extrusion claims ontvangen betreffende de batch ...

   Waarschuwing | 26-02-2021

6. Mölnlycke Health Care AB, FSN-2020-09 (01), Mölnlycke® Procedure Trays & Single Packed Shielded Bladed Trocars

   Mölnlycke has become aware of situations where the protective flanges come away from trocar cannula.

   Waarschuwing | 19-10-2020

7. BALT EXTRUSION SAS, FSN-20210412_Silk Vista MRI Information Error, SILK VISTA

   During the post-marketing surveillance program Balt Extrusion SAS received a customer complaint about an error in the MRI ...

   Waarschuwing | 14-04-2021

8. Mölnlycke Health Care AB, FSN-2020-09 (02), TUR tray

   Mölnlycke has identified a potential safety issue. During a regular inspection, a fault in the sealing machine was identified.

   Waarschuwing | 19-10-2020

9. Globus Medical, FSCA-2024-003, Cannula A, 9mm x 250mm, ExcelsiusGPS

   De hulpmiddelen kunnen mogelijk niet goed worden gesteriliseerd vanwege een interne opening die aanwezig kan zijn bij sommige ...

   Waarschuwing | 19-02-2024

10. Field Safety Notice: Bentley InnoMed GmbH, BeGraft Peripheral Plus Stent Graft System

    In het kader van ons markt toezicht proces is opgemerkt dat tijdens het gebruik van de 7 en 8 mm items, volgens de etikettering 7 ...

    Waarschuwing | 31-05-2017