Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Microtek Medical Ltd. ECL-FSCA-138 - Intraoperative Probe Cover with Long Surgi-Tip

   Er is een zeer kleine kans op bacteriële contaminatie van een aantal batches van de intra-operatieve sondehoes. Ecolab heeft ...

   Waarschuwing | 19-07-2019

2. CAPRON PODOLOGIE, 20240408_0003, FAUTEUIL F1 Chairs F1 2000, F1 2000 Ergo, F1 Neo, F1 Neo, Ergo, F1 3000, F1 3000 Ergo

   In collaboration with the company FIMET OY, manufacturer of the Fl armchair base, it has been detected that a weld in the ...

   Waarschuwing | 02-07-2024

3. Limacorporate SPA, FSCA 20240002, Discovery Humeral Stems

   Following the close complaints monitoring, LimaCorporate detected cases of intra-operative difficulty in correctly assembly the ...

   Waarschuwing | 24-06-2024

4. ViennaLab Diagnostics GmbH, FSCA 2024/001, StripAssay®

   The deviations of the schematic representation on the collector sheet from the actual dimensions of the strips of the ...

   Waarschuwing | 11-04-2024

5. HMC Premedical spa, FSN 001/24, ENFit double-lumen polyurethane “Replogle” tube

   HMC and Medicina is voluntarily recalling the batches of the product listed below due to a potential design issue that has been ...

   Waarschuwing | 04-04-2024

6. Medtronic, FA1406, Abre™ Venous Self-expanding Stent System

   Het doel van deze brief is u te informeren dat Medtronic bepaalde lotnummers van het Abre™ veneus zelfontplooiend stentsysteem ...

   Waarschuwing | 19-03-2024

7. 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

8. ArcRoyal uc, an Owens & Minor Company, FSN-2023-J-001, Q66445 Armtray

   ArcRoyal received a customer complaint that Q66445 Arm tray was labelled with product description sectiotray. Upon internal ...

   Waarschuwing | 28-11-2023

9. CamDiab Ltd, ET5604, CamAPS and mylife CamAPS

   Er is een softwarefout geïdentificeerd in de mylife CamAPS FX app in versie 1.4(174) en eerdere versies, waarbij de aftelling ...

   Waarschuwing | 21-11-2023

10. Masimo Corporation, TC-I Reusable Tip Clip Sensor; MDSS ref: MDD23.148, TC-I Reusable Tip Clip Sensor

    Masimo identified TC- I Reusable Tip Clip sensors with higher than expected variability in SpO2 readings that are outside of the ...

    Waarschuwing | 03-10-2023