Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
1.683 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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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 ...
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SLE Ltd, CAPA-00395-FSN-01, Reusable and Single Use Flow Sensors
We hebben een toename van klachten ontvangen van klanten over alarmen tijdens kalibratie van de flowsensoren.
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Aesculap AG, FSCA287, STERILCONTAINERSYSTEM BASIS / AICON
De sterilisattecontainer is gemaakt van geanodiseerd aluminium en biedt aanzienlijke functionele en veiligheidsvoordelen in ...
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Corcym S.r.l., REC-000703, Carbomedics Prosthetic Heart Valves and Carbomedics Carbo-Seal® and Carbo-Seal® Valsalva Ascending Aortic Prostheses
Corcym detected that the products listed in Attachment A might present leaflets with a thickness of the Pyrolitic carbon coating ...