Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
3.586 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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BioFire Diagnosticss, LLC, FSCA 5761-2, BIOFIRE FILMARRAY TORCH Base
The purpose of this letter is to update you with revised information (shown in red) of a product correction involving the ...
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Stryker Joint Replacement, RA2024-3598242, Mako Total Knee
Stryker has discovered specific to the applications listed in Table 1 an increase in the Software Error #3 (SE3) error code when ...
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Waldemar Link GmbH & Co.KG, R-2024-05, Endo-Model-M & Endo-Model SL (Tibial components)
There is a risk that the blind screws of the modular tibial component cannot be loosened intraoperatively. This is necessary if ...
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MEDTRONIC b.v., FA1412, 37307 Activa SC 48054 Pocket Adaptor for Deep Brain Stimulation
Met deze brief willen wij u informeren over een probleem met betrekking tot de geschiktheidsstatus voor magnetische ...
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Boston Scientific Corporation, 97205052-FA, Direxion™ Fathom™-16 System Pre Loaded Torqueable
Boston Scientific start een terugroepactie van twee partijen Direxion™ Fathom™ Microkatheters, waarbij mogelijk lijm aanwezig is ...
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Medtronic Inc., FA1416, Cobalt™ XT DR Cardiac Resynchronization Therapy Defibrillator & Evera™ XT DR Defibrillator
Medtronic is retrieving the device(s) listed below from your inventory. Your Medtronic representative will collect the device(s) ...
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Atrium Medical Corporation, 3011175548-05/08/2024-001-R, Advanta VXT and Flixene Vascular Graft
Between 27 December 2023 and 17 April 2024, Atrium Medical Corporation/Getinge received eight (8) complaints reporting that the ...
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Fysicon B.V., CAPA24002, DataLinQ 2PAD
With the distribution of 2PAD v4.0.1 and v4.0.2 an incorrect data configuration was made available for the Medtronic programmer ...
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Integra LifeSciences (Ireland) Limited, 2024-HHE-006, Cusa Excel 23kHz Straight Handpiece
The decision to conduct a voluntary correction of the product was based on the following: through an internal investigation of ...
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Siemens Healthcare Diagnostics Inc., POC 24-015, RAPIDPoint® 500e Blood Gas System
Siemens Healthineers has identified an issue with the RAPIDPoint 500e system software version 5.3. This issue affects how the ...