Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
3.586 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Randox Laboratories Ltd., REC718, CYSTATIN C CALIBRATOR (CYSC CAL)
Randox Laboratories is erachter gekomen dat de Cystatin C Calibrator uit de CYS 2699-serie een negatieve afwijking vertoont in ...
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Life Technologies Holdings Pte Ltd., PR# 756842, on PGM™ Dx Instrument System
This communication is to inform you that Thermo Fisher Scientific has recently completed penetration testing on the Torrent ...
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D.O.R.C. Dutch Ophthalmic Research Center (International) B.V, 2023-0023, DORC Directional Laser Probe
De gebruiker kan problemen ondervinden om de laservezel uit te schuiven of in te trekken. In sommige gevallen kan het ook ...
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Fritz Stephan GmbH, QS.19-14434, EVE IN; EVE TR; EVE NEO
Fritz Stephan GmbH was informed about a case in which toggling of the measured value display resulted in ventilator failure.
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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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Siemens Healthcare Diagnostics Inc, POC 24-007, Atellica UAS 800 Analyzer
Siemens Healthcare Diagnostics Inc. has confirmed an issue that has the potential to misidentify samples when ALL the following ...
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Gyrus ACMI, Inc. (Olympus Surgical Technologies America), QIL FY24-EMEA-36-FY24-OSTA-06, SOLTIVE SuperPulsed Laser System
As part of Olympus’ post market surveillance of Soltive Laser use, including a review of customer complaints and adverse events, ...
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Zeta Corporation, FSCA-1122024-001, Several products Zeta Corp / See FSCA-1122024-001 List of Products
De teruggeroepen producten waren ten onrechte geëtiketteerd met “CE/IVD”, terwijl ze hadden moeten worden gemarkeerd als ...
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Medtronic B.V., FA1405, Hugo RAS Surgeon Console
De netvoeding voorziet de volledige chirurgconsole van stroom, behalve de 3D-monitor, die een eigen voeding heeft. Als de voeding ...
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Medtronic B.V., Hugo RAS Tower, 120V Hugo RAS Tower, 240V Field replaceable unit. 1GB Switch, 24port Field replaceable unit. NRT, 1GB SWITCH, 24PORT