Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
763 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Seemann Technologies 012021 - Sterile disposable bipolar forceps cable
The sterile disposable bipolar forceps cables are listed on the EC Directive certificate of the Notified Body not as a Class I ...
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ViennaLab Diagnostics GmbH FSCA 2021_001 - α-Globin StripAssay®
Internal stability testing has revealed an impaired performance of the HS-Taq DNA Polymerase, a stand-alone component of the ...
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MatOrtho Limited, FSN-FSN-21-005, ADEPT®
This FSN is to inform you that the indications and contraindications in the current instructions for use for these devices have ...
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Drägerwerk AG, FSN-PR112908, Perseus A500 Ceiling Version
During the course of our global market surveillance activities, we have become aware of a case in which a Perseus A500 Anesthesia ...
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CARMAT SA, FSN-G000062421/02, Total Artificial Heart system AESON
In december 2021 stuurde CARMAT SA onderstaande veiligheidswaarschuwing aan betrokkenen voor het mogelijk falen van het kunsthart ...
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Maillefer Instruments Holding SARL, FSN-HHE-2021-05, PATHFILE; PROGLIDER; PROTAPER GOLD
During regular internal testing, Dentsply Sirona has detected a sporadic sealing issue on a production of blisters. Some of these ...
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NuVasive, Precice Unyte and Short IFU Update FSN, Precice System
NuVasive Specialized Orthopedics, Inc. (NSO) voluntarily issues this Field Safety Notice (FSN) to inform healthcare providers of ...
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Promed FSCA 05_2021 - Promed schoenen
Sommige schoenen vertonen sporen van verontreiniging met schimmel.
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Northgate Technologies, Inc., FSNCAPA 21062, Autolith Touch BSC
Boston Scientific Corporation (BSC), een distributeur van de AUTOLITH® TOUCH bipolaire elektrohydraulische lithotripsieapparaat ...
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Contrel Europe, QE-276, GyneFix & GYN-CS
De autoriteiten hebben ons erop gewezen dat de classificatie “MRI veilig” wettelijk niet toegelaten is. De juiste classificatie ...