Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
3.594 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Roche Molecular Systems, FSN-CN-516475, cobas z 480 analyzer
Roche received complaint cases alleging false positive or invalid results with select cobas® 4800 IVD assays.
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Roche Diagnostics GmbH, FSN-CN-525642 (SB-CPS-2020-009), cobas c 503 analytical unit
Roche Diagnostics GmbH would like to inform you that they have received three customer complaints regarding low Quality Control ...
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KARL STORZ SE & Co. KG, FSN-200829959, HYSTEROMAT E.A.S.I.® SCB
Bij de controle van de technische documentatie is vastgesteld dat KARL STORZ momenteel niet over voldoende klinisch bewijs ...
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Synthes GmbH, FSN-1882308, RIA 2 (Reamer Irrigator Aspirator)
Synthes GmbH initieert een vrijwillige veiligheidsmededeling voor alle lotnummers van de RIA 2 (Reamer Irrigator Aspirator 2).
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Galil Medical Ltd, FSN-92611185-FA, Cryoablation Needles
Boston Scientific (BSC) is initiating a Product Advisory for the IceFORCE™, IcePearl™, IceRod™, IceSphere™, IceSeed™, IceEDGE™ ...
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Finndent Oy, FSN-2935-001-005, FD-8000
Urgent Field Safety Notice FD-8000 Premature wear of brake-arm mechanics.
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Respironics California, LLC, FSN-FSCA 86600052A_IR, V60 (Plus) ventilator
Er is een probleem geconstateerd bij de Philips V60-beademingsapparaten dat een risico kan vormen voor patiënten of gebruikers ...
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Galt Medcial Corp., FSN-1649395-11-16-2020-001, Centeze® /Centesis Catheter
Centeze catheters associate with the lots referenced in this FSN may have a tip geometry with a thicker wall, resulting in a more ...
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Siemens Healthcare Diagnostics Inc., FSN-ASW21-01, Atellica IM 1300 Analyzer and Atellica IM 1600
Siemens Healthcare Diagnostics has identified an issue with the Atellica Solution products through investigation of customer ...
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Olympus Medical Systems Corporation, FSN-QIL 153-012, Several GF-EUS ultrasound endoscopes
Olympus is writing to inform you of a Field Safety Corrective Action for the Olympus Endoscopic Ultrasound Endoscopes (‘EUS’).