Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
467 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Field Safety Notice: Autonomic Technologies - Pulsante SPG Microstimulator System
A change was made to the Pulsante® SPG Microstimulator (the implantable component) which was not properly validated. This change ...
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Field Safety Notice: Abbott Vascular - Absorb (GT1) Bioresorbable Vascular Scaffold
In samenwerking met de Europese regelgevende agentschappen (bevoegde autoriteiten en onze aangemelde keuringsinstantie (notified ...
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Field Safety Notice: Optimed - sinus-SuperFlex-635
The details of the label on the packaging do not correspond to the delivered product. The information of the inner label on the ...
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Field Safety Notice: Aesculap - Diamond burr with coarse and extra-coarse grain
With this letter, we would like to inform you that Aesculap AG is initiating a global voluntary product recall of diamond burrs ...
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Field Safety Notice: Intuitive Surgical, vrijgavekit voor de da Vinci® Xi EndoWrist Stapler
Intuitive Surgical heeft klachten ontvangen dat het instrument tijdens gebruik is gebroken. Fabrikant: Intuitive Surgical ...
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Field Safety Notice: Cook - Zenith Alpha™ Thoracale Endovasculaire prothese
Middels deze veiligheidskennisgeving willen wij uw aandacht vestigen op een aantal aspecten van de nieuwe versie van de ...
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Field Safety Notice: ArcRoyal - Custom Procedure Trays Containing BD Plastipak 100 ml Syringe 10-005358
The field safety notice has been initiated as syringes showed leakage past the stopper during routine real time stability tests, ...
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Field Safety Notice: Aesculap - MINOP INVENT 30° TROCAR, FH620R
We were informed that the insulation of an electrode has been damaged intraoperatively when pulling it out of the MINOP INVENT ...
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Field Safety Notice: Advanced Medical Solutions, LiquiBand FIX8
AMS will be temporarily removing revision 03 of the Instrucions for Use (IFU) from use and reintroducing revision 01. Fabrikant: ...
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Field Safety Notice: CONMED Corporation, Hyfrecator® 2000 Electrosurgical Units
From December 2, 2015 to January 3, 2017, the Accessory Packages in the Hyfrecator® 2000 ESU cartons were packaged in error by ...