Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
3.367 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Medtronic Inc., FA1418, CareLink Programmer
Medtronic CareLink™ 2090 Programmers met serienummerprefixen PKK0 en PKK1 kunnen autonome cursorbewegingen weergeven wanneer de ...
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Ziehm Imaging GmbH, SIKK2201, Several Ziehm device types and OEM products
Voor de hieronder vermelde systemen is vastgesteld dat mechanische belasting zoals schokken (bijv. laten vallen) of stoten het ...
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SENTINEL CH. S.p.A., 01/2024, CALiaGold® pierceTube
Following a customer complaint, Sentinel detected a defect in some collection tubes of the lots referenced above. The defect is ...
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Abbott Laboratories, FA14JUN2024, Alinity hq Analyzer
Abbott has identified the following issues when using Alinity hq Analyzer software version 5.6 and below which will be corrected ...
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BioFire Diagnostics, LLC, FSCA FA-TWD-000007, BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel
Uit onze gegevens blijkt dat u mogelijk het product uit bovenstaande tabel in gebruik hebt. Het doel van deze brief is om u te ...
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Proteomedix AG, 006-24, Proclarix Risk Calculator
An overestimation of free PSA results was observed by bioMérieux (VIDAS® FPSA - Ref. 30440 - Slow Drift leading to potential ...
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Phadia AB, QA2023-05, EliA GBM Well
Phadia AB distributed a Field Safety Notice (QA2023-05) informing users that specific samples may produce false positive EliA GBM ...
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Roche Diagnostics GmbH, cobas EGFR Mutation Test v2
Roche received complaints from customers reporting the generation of false Mutation Detected results for the EGFR exon 20 ...
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Decon Wheel AB, FSCA_rek20240614_Infinity, Infinity
Decon heeft meldingen u t de markt ontvangen dat de montageplaat waarmee het tussenstuk aan de voorkant van de Infinity is ...
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Siemens Healthcare Diagnostics Inc., ACHC 24-03, Atellica CH Iron3
In March 2024, Siemens Healthineers issued an Urgent Field Safety Notice (UFSN), ACHC24-03.A.OUS, for the Iron3 product listed in ...