Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
3.594 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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IRadimed Corporation, FSN-3005053560-03/01/2023-001-C; MDSS ref.: MDD23.053, 1057 MRiduim MRI Infusion Syringe Adapter Set
Iradimed has received reports of 1057 Syringe Adapter Sets not properly venting air into the attached syringe during use, which ...
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FSCA-001, TIB Molbiol Syntheselabor GmbH, LightMix• ModularDx Sapovirus
TIB Molbiol Syntheselabor GmbH heeft een klacht van een klant ontvangen over de LightMix® ModularDx Sapovirus set. De ...
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Helena Biosciences Europe, FSN-NC661, Collagen
This lot of Collagen has demonstrated poor aggregation response at very low doses of 1.25ug/mL
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Richard Wolf GmbH, FSN-FSCA700020652, FLEX. GRASP. FORCEPS or FLEX. BIOPSY FORCEPS
We have received complaints from users stating that the forceps can no longer be opened during use. Our investigation has shown ...
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Datascope Corp., FSN-2249723-02/02/2023-005-C, Cardiosave Intra-Aortic Balloon Pumps
Datascope/Getinge has identified that, while conducting Safety Disk testing, expired tubing was used on the test fixture ...
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Philips Medical Systems Nederland BV, FSN-2023-IGT-BST-002, Philips Azurion
Philips has become aware of a potential safety issue with the Philips Azurion System R2,2.0, R2.2.1, R2.2.3, R2.2.S and R2.2.6, ...
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Maquet Cardiopulmonary GmbH, 781869, QUADROX-i.-iD, VHK 11000, VKMO 10000.11000
Maquet Cardiopulmonary GmbH (MCP) became aware of various failure modes in regard to the QUADROX-i/ -iD, VHK 11000 and VKMO ...
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Biocartis NV, FSN-BC-020988, Idylla™ Instrument Test
In the context of a complaint investigation, Biocartis has identified a set of Instruments manufactured between September 2021 ...
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Elekta, Inc., FCA-IMS-0044, Monaco RTP System
Een reeks stappen die door de gebruiker worden uitgevoerd, bestaande uit een initiële optimalisatie, uitbreiding van een ...
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Eakin Surgical Limited, ESL-2301, Diathermy Suction
Testing of the Diathermy Suction Devices has revealed non-compliance with IEC 60601-2-2-2017 standard: Medical electrical ...