Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Mevion Medical Systems FSCA_220126 - Mevion S250i

   Mevion was informed of an instance where a user changed only the Setup isocenter in ARIA in a previously approved plan, without ...

   Waarschuwing | 24-02-2022

2. SEBIA, FSN-FSCA-02-2022-01, CAPI 3 IMMUNOTYPING

   We inform you that a user of these kits highlighted an inversion between the anti-Ig M and anti-Lambda antisera. Our ...

   Waarschuwing | 24-02-2022

3. Sanquin Reagents FSN181410 - MabTrack level infliximab kit

   There is a small chance that your kit contains a detective microtiter plate. lf your kit contains a detective microtiter plate, ...

   Waarschuwing | 23-02-2022

4. Drägerwerk AG & Co KGaA, FSN-PR114992, Evita V300; Evita V500; Babylog VN500

   The abovementioned ventilators use specially hardened operating systems. However, one of the used operating systems cannot be ...

   Waarschuwing | 22-02-2022

5. HS Doms GmbH, FSN-C-103, HS-2010

   At examination of a broken backrest, we saw, that the welds were not done well by our supplier and so the backrest broke into two ...

   Waarschuwing | 24-01-2022

6. implantcast GmbH FSCA_22001 - AGILON® glenoid components

   We have ascertained that some individual screw holes in our AGILON® glenoids do not conform to the specification in the technical ...

   Waarschuwing | 17-01-2022

7. Immucor EU FA #21-02 - FA-WKS-21-002 - MATCH IT! Platelet Antibody Software

   Naar aanleiding van een klachtenonderzoek hebben wij vastgesteld dat bij gebruik van de MATCH IT! Platelet Antibody Software per ...

   Waarschuwing | 10-01-2022

8. Contrel Europe, QE-276, GyneFix & GYN-CS

   De autoriteiten hebben ons erop gewezen dat de classificatie “MRI veilig” wettelijk niet toegelaten is. De juiste classificatie ...

   Waarschuwing | 14-12-2021

9. Henry Schein, 5866, IV Sets/ Accessories - Henry Schein

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

   Waarschuwing | 07-12-2021

10. Drägerwerk AG & Co KGaA, PR109794, Evita V300; Evita V500; Babylog VN500

    In the course of our global market surveillance activities, we have become aware of sporadic cases in which the above-mentioned ...

    Waarschuwing | 23-11-2021