Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Acutronic Medical Systems AG, FSCA-24-001, fabian HFO, Therapy, +nCPAP Ventilators

   Acutronic Medical Systems AG is pleased to make available the attached Addendum to the fabianTM Instructions for Use (IFU) for SW ...

   Waarschuwing | 18-03-2024

2. Philips Medizin Systeme Böblingen GmbH, FSCA 2023-CC-HPM-044, DIVA 24 Inch Widescreen LCD Touch Display

   Het aanraakscherm van het DIVA 24-inch LED-breedbeeldscherm is een van de Philips-schermen die beschikbaar is voor gebruik met ...

   Waarschuwing | 15-03-2024

3. Sleepnet Corporation, 2024-FSN-1, Mojo + Mojo2+iQ 2+Phantom 2

   Maskers met magneten van Sleepnet Corporation – Potentiële magnetische interferentie met bepaalde medische producten. In dit ...

   Waarschuwing | 14-03-2024

4. RaySearch Laboratories AB (publ), 130646, RayStation

   This notice concerns a use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was ...

   Waarschuwing | 12-03-2024

5. Mikrogen GmbH, M23004, recomLine HIV Rev001 Build001.stc

   Programming gap with an extremely rare band ratio of gp41 to gp36, resulting in a borderline output instead of positive, ...

   Waarschuwing | 06-03-2024

6. Angiokard Medizintechnik GmbH, Angiokard 2024-1, n.a. - Einwegehahn, verbaut als Set-Komponente

   Male side of the 1-way valve cannot be securely connected.

   Waarschuwing | 05-03-2024

7. Medtronic Xomed, Inc, FA1255 Phase II., NIM™ Standard Reinforced EMG Endotracheal Tube & NIM CONTACT™ Reinforced EMG Endotracheal Tube

   NIM™ Standaard gewapende EMG endotracheale tube en NIM CONTACT™ Gewapende EMG endotracheale tube zijn siliconentubes waarvan de ...

   Waarschuwing | 26-02-2024

8. ChipSoft BV, RMT501, HiX 6.3

   Met softwareaanpassing 199593 (HiX 6.3, hotfix 71.0) is geneesmiddelgroep 'Niet weergeven in afleverhoeveelheid' toegevoegd. Bij ...

   Waarschuwing | 22-02-2024

9. Arrow International LLC (Subsidiary of Teleflex Incorporated), EIF-000556, Radial Artery Catheterization Set

   Teleflex is initiating this voluntary FSCA for the above-mentioned products due to reports received indicating a potentially ...

   Waarschuwing | 19-02-2024

10. Dispo Medical, 23.10.017.QA.45243.FSCA, Bacterial Filter and Insufflation Tube 22 mm. 50116.

    Due to temporary problems with the injection moulding mould at our supplier, it may be possible that some of the connectors used ...

    Waarschuwing | 07-02-2024