Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. NRT-Nordisk Røntgen Teknik A/S PR20210830-01 - Celex and Intelli-C EU

   This FSN is distributed to inform users about a risk that a friction rubber block, used in the clamping mechanism of the ...

   Waarschuwing | 26-01-2022

2. Acandis GmbH FSCA 22-001 - DERIVO® 2 Embolisation Device

   We have received an increasing number of complaints from customers who have reported difficulty in delivery of devices through ...

   Waarschuwing | 26-01-2022

3. Level 1® Fast Flow vloeistofverwarmingssystemen: Notificatie van opschorting CE markering

   Op 21 januari 2022 stuurde Smiths Medical ASD onderstaande notificatie aan betrokkenen over het opschorten van Level 1® Fast Flow ...

   Waarschuwing | 24-01-2022

4. Baxter Healthcare SA, FSN-FA-2021-058, transfer Set (MiniCap Extended Life PD Transfer Set (6”) with Twist Clamp)

   Baxter Healthcare Corporation is issuing a Device Correction for the MiniCap Extended Life PD transfer sets listed below. The ...

   Waarschuwing | 24-01-2022

5. MICROVENTION INC, FSN-FCA202105, HydroCoil Embolic System - HYDROSOFT 3D

   Meer specifiek wordt op het tweede van de vier verwijderbare etiketten tweemaal verwezen naar de “HydroCoil™ 10”, in plaats van ...

   Waarschuwing | 24-01-2022

6. 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

7. Zimmer CAS, FSN-ZFA 2022-00004, NavitrackER Markers

   Zimmer CAS is conducting a lot specific medical device Field Safety Corrective Action (removal) for one lot of the NavitrackER ...

   Waarschuwing | 21-01-2022

8. Ventana Medical Systems Inc, FSN-CN-583565 (SBN-RDS-PathologyLab-2022-001), BENCHMARK ULTRA

   Roche received a complaint reporting a fluid leak within the BenchMark ULTRA instrument that created an electrical short inside ...

   Waarschuwing | 20-01-2022

9. Siemens Medical Solutions USA, Inc. Ultrasound, FSN-US030/21/S + US001/22/S (supersedes US029/21/S), ACUSON Sequoia

   In Sequoia 1.2 treedt er een berekeningsfout tijdens de meting op wanneer u het 2D-hulpmiddel voor trace (handmatige trace) ...

   Waarschuwing | 20-01-2022

10. RaySearch Laboratories AB (publ), FSN-90375, RayStation

    If a new primary image set is selected while the cine loop is running, the primary image set will be displayed as both primary ...

    Waarschuwing | 20-01-2022