Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Olympus, QIL 151-010, MAJ-209 SINGLE USE SUCTION VALVE

   Olympus has initiated this action after receiving a complaint of a MAJ-209 breaking during a patient procedure and got stuck in ...

   Waarschuwing | 14-03-2019

2. ARB Medical_Medpace - Rebound HRD and HRD-V

   This FSCA/recall is due to complaints of the fracture of the frame (ring) of the product (which is implanted to repair hernias) ...

   Waarschuwing | 04-10-2018

3. Field Safety Notice: COOK Medical - Stamey Needle, Clarke-Reich Laparoscopic Knot Pusher, Endoscopic Introducer/Extractor, Pereyra Ligature Carrier ‘75®, Pereyra-Raz Ligature Carrier™

   We have identified the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, ...

   Waarschuwing | 24-04-2017

4. Field Safety Notice: ELLA-CS - Danis Procedure Pack (Basic)

   Based on analysis of a returned product, company ELLA-CS, s.r.o. has identified that an unintended movement of the safety valve ...

   Waarschuwing | 14-02-2017

5. Fresenius Medical Care AG & Co KGaA, FSN-SO 2020 1516, AquaC UNO

    During regular quality inspections within Fresenius Medical Care of AquaC UNO H devices we discovered incorrectly crimped ...

   Waarschuwing | 26-08-2020

6. Davol Inc. Subsidiary of C. R. Bard Inc, SUR-23-4657, Ventralight ST Mesh with Echo PS Positioning Sys

   BD heeft door klachten van klanten vastgesteld dat de e balloncomponent van het Ventralight ST-gaas met het Echo ...

   Waarschuwing | 22-05-2023

7. Coloplast A/S, FSN-FSCA_In-Ka_20221003, In-Ka Ureteral balloon dilatation catheter kit

   De vervaldatum op de IN-KA® ureterale ballondilatatie katheterset is niet correct. De houdbaarheid van één component in de set ...

   Waarschuwing | 13-10-2022

8. Avanos Medical FCA-2022-002 - CORTRAK* 2 Enteral Access System (EAS)

   Avanos Medical is issuing a voluntary Field Safety Notice (FSN) for the CORTRAK* 2 Enteral Access System (EAS) due to reports of ...

   Waarschuwing | 11-05-2022

9. Medtronic FA863 - My Therapy App for Sacral Neuromodulation Therapy

   Het probleem doet zich voor wanneer een nieuw programma op een InterStim implanteerbare neurostimulator (INS) met de A510 ...

   Waarschuwing | 16-05-2019

10. Field Safety Notice: Baxter - Artis/Evosys dialysis systems

    The current software version allows for the possibility of resetting and continuing patient treatment without following the ...

    Waarschuwing | 11-04-2017