Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
74 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Micro Therapeutics Inc. DBA ev3 Neurovascular, FSN-FA929, PipelineTM Flex Embolization Device (with Shield TechnologyTM)
Medtronic is providing this notice regarding a labeling update to ensure awareness among Pipeline™ Flex and Pipeline™ Flex with ...
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The Magstim Company Ltd, FSN-FCA-2020-02, Neurosign V4
Magstim are issuing a voluntary corrective action following reports that manipulation of the cable which connects the ...
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Elekta Instrument AB, FCA-EIAB-0008, Leksell Vantage Arc System
Elekta has found that the design of the Instrument Carrier is not optimal which may cause the locking mechanism at the interface ...
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Medtronic Inc FA912 Verify Therapy App
This letter is to notify you of the correction of an inadvertent automatic update to Model A511 Clinician Therapy Application ...
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The Spectranetics Corporation D055703 Bridge® Occlusion Balloon
The Bridge Occlusion Balloon catheter is indicated for use for temporary vessel occlusion of the superior vena cava in ...
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Medtronic FA906 - Pipeline Flex Embolization Device
Medtronic has identified the potential for device fracture at the distal section during use due to a weakened bond in a subset of ...
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Medtronic Inc. FA889 SynchroMed® II Implantable Infusion Pump
Bij een permanente motorstop zal de medicamenteuze infusietherapie stoppen, wat kan leiden tot terugkeer van onderliggende ...
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LivaNova USA, Inc., NM-HOU-2019-002 VNS Therapy® SenTiva® Generator
Unintended device disablement may occur in a small population of Model 1000 generators (Serial Numbers ≥ 100,000) due to a ...
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Natus Medical Denmark DOC-035720 Chartr EP 200
It has been determined that the device does not fully meet current regulatory standard for basic electrical safety and essential ...
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Microtek Medical Ltd. ECL-FSCA-138 - Intraoperative Probe Cover with Long Surgi-Tip
Er is een zeer kleine kans op bacteriële contaminatie van een aantal batches van de intra-operatieve sondehoes. Ecolab heeft ...