Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Ivoclar Vivadent AG, 10-2022-001, VivaPen Snap-On Cannulas

   Door een afwijking in de productie van de canules zijn er enkele gebrekkige VivaPen-canules in omloop gekomen. In zeldzame ...

   Waarschuwing | 05-12-2022

2. CamDiab Ltd, FSN-ET4339, mylife CamAPS

   Er is een softwarefout geconstateerd in de mylife CamAPS FX-app versie 1.4 (153) en eerdere versies wanneer een standaardbolus ...

   Waarschuwing | 13-10-2022

3. Henry Schein Inc., Control 6361, Self-Aspirating Syringe Dual Action Metric 1,8ml

   The metal ring that is attached to the cartridge holder of the syringe may be loose, allowing it to move freely, which is not ...

   Waarschuwing | 06-10-2022

4. Astraia software GmbH, 2022-02-02 CAPA AST-7150,astraia - software for women's health - obstretic and gynaecological database application

   We would like to inform you as the user/reseller of astraia about a possible bug in transferring measurement data, used for the ...

   Waarschuwing | 29-09-2022

5. ShenZhen Cleanmo Technology, IT2045270, flocked swabs for nasal samples collection

   The AR received the signal that the exported swabs are missing the four-digit number of the Notified Body.Through investigation, ...

   Waarschuwing | 28-09-2022

6. Löwenstein Medical SE & Co. KG, FSCA2022013, elisa 600, elisa 800 und elisa 800 vit

   De NIST-connectoren vormen de verbinding tussen de gasslangen en de ventilator. Elke NIST-connector is voor een specifiek gastype ...

   Waarschuwing | 22-09-2022

7. Thermo Fisher Scientific, FSN-2022-009, SAB GLUC AGAR +GENTAM+CHLORAMPH

   A technical investigation has concluded that there is no inhibition of one target organism ( Pseudomonas aeruginosa) on this Lot

   Waarschuwing | 16-09-2022

8. CareDx AB, A-2022-114, QTYPE 11

   A known 8*50:01:01:02 sample was typed as 8*50:02 due to an incorrect reactivity in the mix in H7 FAM. 8*50:01:01:02, ...

   Waarschuwing | 16-09-2022

9. Astraia software GmbH, 2022-02-02 CAPA AST-7150, Astraia - software for women's health

   We would like to inform you as the user/reseller of astraia about a possible bug in transferring measurement data, used for the ...

   Waarschuwing | 22-08-2022

10. Hamilton Medical CER 96908 - HAMILTON-C6 ventilator

    Analysis of customer complaints revealed a hardware issue related to the status indicator board which can become loose and may ...

    Waarschuwing | 14-07-2022