Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
1.888 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Brainlab AG, CAPA-20250117-002791, Multidisciplinary medical image management SW
Wij schrijven u ter informatie van een mogelijk veiligheidsprobleem bij het gebruik van Brainlab Origin Data Management (ODM) ...
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Rocket Medical PLC, CUST-OCC824/829 (NVFSN-08), Rocket Thoracentesis Catheter 6FG & 8FG
Rocket Medical PLC has identified a manufacturing issue affecting devices from the lot(s) listed in Table 1. During the ...
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Biomet UK Ltd, ZFA-2024-00261, G7® Acetabular System - Bispherical Cup
Component loosening is a contributing factor for the reported revision cases. Since August 2020, a total of 28 product complaints ...
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Maquet Cardiopulmonary GmbH, 1186064, Heater-Cooler Unit HCU 40 High.Low Voltage
The manufacturer became aware of this issue in course of 37 complaints. While 35 earlier complaints were detected by visual ...
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Ovesco Endoscopy AG, CC-2025-002, colonic FTRD Set
In this LOT, an incorrect endoscope sleeve was accidentally included. This sleeve is too short for the system. This does not lead ...
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Mevion Medical Systems, Inc., CAPA-00079, Mevion S250i
Radiation Therapists reported an issue during patient setup for two cases. After applying the CBCT deltas and completing the ...
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Sedana Medical Ltd, CRN00FY1L; QE-000487, Sedaconda Syringe
A potential issue has been identified with the connection between the syringe (filled with isoflurane or sevoflurane) and the ...
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Remel Inc, FSN-2024-004, VERSATREK MYCO AS
An internal technical investigation confirmed that VERSATREK MYCO AS, 5/BX, Y71144-2 lot 440824 is labelled with an incorrect ...
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Spectrum Medical S.r.l., CACP0125, Quantum Perfusion Centrifugal Blood Pump
Spectrum Medical S.r.l., als fabrikant van de Quantum Perfusie Centrifugale Bloedpomp met Geïntegreerde Druksensoren Lange ...
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Medtronic, FA1206, Medtronic Neuromodulation - Percept PC Implantable Neurostimulator (INS)
In oktober 2021 heeft Medtronic een kennisgeving uitgegeven waarin gebruikers worden geïnformeerd dat een cardioversieprocedure ...