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. Coloplast A/S, FSN-FSCA_In-Ka_20221003, In-Ka Ureteral balloon dilatation catheter kit

   De vervaldatum op de IN-KA® ureterale ballondilatatie katheterset is niet correct. De houdbaarheid van één component in de set ...

   Waarschuwing | 13-10-2022

3. Covidien llc, FA1281, 60480 Endo Stitch V-Loc 180 Absorbable Reload 17245 Endo Stitch V-Loc PBT Non-Absorbable Reload

   Medtronic heeft meldingen ontvangen dat naalden tijdens endoscopisch hechten breken. Tot de mogelijke schade behoren een ...

   Waarschuwing | 06-10-2022

4. Abbott Vascular, Clip Delivery System September 07 2022, MitraClip and TriClip Delivery Systems

   Het hogere aantal meldingen betreft clips waarbij het niet mogelijk is de ‘definitieve armhoek te bepalen’ (EFAA,Establish Final ...

   Waarschuwing | 03-10-2022

5. Abbott, Clip Delivery System September 08, 2022, MitraClip- en TriClip- Delivery System(s)

   Het hogere aantal meldingen betreft clips waarbij het niet mogelijk is de ‘definitieve armhoek te bepalen’ (EFAA, Establish Final ...

   Waarschuwing | 27-09-2022

6. W. L. Gore & Associates, Inc. Medical Products Division, 2017233.09.15.2022.001-R, GORE® CARDIOFORM ASD Occluder

   Gore has identified one batch of GORE® CARDIOFORM ASD Occluder devices that was incorrectly released following a documented ...

   Waarschuwing | 26-09-2022

7. Leica Microsystems (Schweiz) AG, FSN-CAPA-HER-MD-22-007, ARveo 8, ARveo, M530 OHX, PROvido

   During internal testing Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics ...

   Waarschuwing | 05-09-2022

8. Intuitive Surgical, ISIFA2022-05-C, Large / Medium-Large / Small Clip Applier

   This Field Safety Notice is to notify you of the potential for unexpected motion while using the da Vinci S/Si and X/Xi EndoWrist ...

   Waarschuwing | 22-08-2022

9. GELITA MEDICAL GmbH, FSN-CR-22-006, GELITA-SPON STANDARD, GELITA-SPON RAPID3, GELITA ENT X-BLOD, GELITA ENT X-DENSE, GELITA ENT X-PAND, GELITA ENT X-PASTE, GELITA-SPON POWDER

   In re-testing ordered by the manufacturer, the endotoxin concentration of the product in some samples has been measured above the ...

   Waarschuwing | 16-08-2022

10. Meridian Medical Oy, FSN-FIMEA-V5818, Valon

    Due to an incident with a Valon TT laser, we would like to inform you that the operating surface of the touch screen must be ...

    Waarschuwing | 21-07-2022