Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Medtronic FA937 - Medtronic Cardioblate™ CryoFlex™ Surgical Ablation Devices

   Medtronic’s investigation process identified the above CryoFlex devices underwent a manufacturing process that may have resulted ...

   Waarschuwing | 30-10-2020

2. Siemens Healthcare GmbH-UI XP004/19/S (FSN) and XP006/19/S (FSCA) - UROSKOP OMNIA and UROSKOP OMNIA MAX

   This letter is to inform you of a potential problem and hazard to persons when positionirig the monitors of the monitor support ...

   Waarschuwing | 27-02-2019

3. Gyrus ACMI, Inc., SG PK CUTTING FORCEPS, 5MM, 33CM. Olympus

   The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.

   Waarschuwing | 23-01-2024

4. Cook Incorporated 2019FA0008 Guardia™ Access - K-JETS-7019, Guardia™ Access Nano - K-JETS-551910

   De embryo transfer katheters met lotnummer 8361746 en 9502915 kunnen een gebogen distale tip hebben. Dit kan leiden tot ...

   Waarschuwing | 03-10-2019

5. Covidien llc, FSN-FA967, 178083: Surgiwand™ II Auto Suture™ Suction and Irrigation Device 5mm/with L-Hook Tip 5mm/ Spatula 5mm

   The purpose of this letter is to advise you that Medtronic is voluntarily recalling specific production lots of its Covidien ...

   Waarschuwing | 24-03-2021

6. Coloplast A/S, FSN-FSCA_Elefant_20200903, ELEFANT® Suction/irigation device

   Urgent Field Safety Notice ELEFANT® SUCTION/IRRIGATION DEVICE for Specific lots.

   Waarschuwing | 15-09-2020

7. FertiProNV, CAPA 2209-03, FertiCult Mineral Oil

   FertiPro recently received a complaint of FertiCult Mineral Oil - lot FP21FM28 about decreased embryo development rate and ...

   Waarschuwing | 04-10-2022

8. Siemens Healthcare GmbH, FSN-UI XP024/20/S and XP026/20/S (FSCA), UROSKOP OMNIA and UROSKOP OMNIA MAX

   lnstallation of additional safety mechanism for monitor support arm of Uroskop Omnia and Uroskop Omnia Max.

   Waarschuwing | 21-09-2020

9. Galil Medical SM091-2019 - Visual-ICE Cryoablation System

   The desiccant tubes’ robustness and ability to remove moisture from the gas system may have been compromised. This additional ...

   Waarschuwing | 24-01-2020

10. KARL STORZ SE & Co. KG-23-0015, BEYER Antrum Punch, Antrum Punch, Sphenoid Punch, Sphenoid Punch, Sphenoid Punch, Galea Spring Hook, Uvula Retractor, Optical Biopsy and Grasping Forceps, Grasping Forceps, Optical Scissor, Working Insert with steering lever

    It was found that there is not insufficient evidence to show that the reprocessing method of the products was adequately ...

    Waarschuwing | 04-01-2024