Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
763 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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NeuMoDx Molecular, a QIAGEN Company, CAPA-00527, NeuMoDx HIV-1 Quant Assay
In summary, NeuMoDx HIV-1 Quant Test Strip results are reported as standard in IU/ml. A conversion factor is then applied to ...
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Canon Medical Systems Corporation, COM-0000001131, Vantage Orian, Vantage Elan, Vantage Titan
Er is geconstateerd dat sommige maximale SFG-waarden die worden weergegeven in 'Systeeminformatie' van het bedieningsvenster en ...
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Philips Medizin Systeme Böblingen GmbH, FSCA 2023-CC-HPM-044, DIVA 24 Inch Widescreen LCD Touch Display
Het aanraakscherm van het DIVA 24-inch LED-breedbeeldscherm is een van de Philips-schermen die beschikbaar is voor gebruik met ...
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RaySearch Laboratories AB (publ), 130646, RayStation
This notice concerns a use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was ...
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ChipSoft BV, RMT501, HiX 6.3
Met softwareaanpassing 199593 (HiX 6.3, hotfix 71.0) is geneesmiddelgroep 'Niet weergeven in afleverhoeveelheid' toegevoegd. Bij ...
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icotec ag, FSCA 23001, icotec Torque Wrench
icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the ...
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Balt USA,HHE-022, Optima Coil System, Prestige Coil System
The purpose of this letter is to advise you that Balt USA is initiating a Field Safety Corrective Action (FSCA) for specific lots ...
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Ambu A.S, Ambu2023FA00002, Ambu aView 2 Advance
Ambu has received information on two incidents where Ambu® aView™ 2 Advance caught fire when mounted on the VESA holder of the ...
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Roche Molecular Systems, Inc., select Roche assays used on the cobas 5800.6800.8800 systems
The CAPA investigation determined that the root cause of the issue is the influenza A target design of the assay, which was not ...
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ARDO medical AG, FSCA 2023-01, Master
Some devices (Master) can overheat due to an incorrectly assembled circuit board and as a result therefore switches off. This ...