Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
3.586 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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B.Braun Surgical, 400435480, MONOPLUS VIOLET 0(3,5) 150cm HR48 LOOP (M)DDP
From a complaint received from the market, the company detected that some units of the above mentioned reference batch could have ...
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Siemens Healthcare Diagnostics Limited ASI 19-04 Atellica CH 930 Analyzer
The purpose of this communication is to inform you of issues with the Atellica CH 930 Analyzer listed in Table 1 above, installed ...
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Roche Diagnostics GmbH IO-0000166 (SBN-CPS-2019-019) IGG-2 (Tina-quant IgG Gen.2)
As CSF samples have lower concentrations than serum samples, due to carry over, a CSF sample might yield discrepant higher ...
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ConvaTec Limited, 2019-008-011MA & 013MA, HandyVac
De transporttests die op het product in zijn huidige marktverpakking zijn uitgevoerd, zijn mislukt en bevestigen de mogelijkheid ...
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Siemens Healthcare Diagnostics Inc. POC 19-021 Atellica UAS 800 Analyzer
Siemens Healthcare Diagnostics has confirmed that a communication error could be generated on the system application software ...
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Bruin Biometrics CAPA-0056 SEM Scanner 200
Scheurvorming in de kabel naar de actieknop (aan-/uit-functie) leidt tot periodieke/permanente storing bij het inschakelen.
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Randox Laboratories, REC407, Rheumatoid Factor Standard, Liquid Protein Calibra
Randox is conducting a Device Modification for Rheumatoid Factor Standard and Liquid Protein Calibrator for the lots specified in ...
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Respironics California, LLC FSCA 86600042A-IR, FSCA 86600043A-IR, FSCA 86600044A-IR, FSCA 86600045A-IR V60 & V680 Ventilators
The touchscreen must be used to change certain therapy settings. The touchscreens in affected units may become frozen and fail to ...
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Biomet, ZFA 2019-00158, Vanguard XP Tibial Tray
Zimmer Biomet is conducting a medical device Field Safety Corrective Action (Removal) for the Vanguard XP Tibia Tray due to the ...
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adeor medical AG, MI001, MSI biopsy instruments
According to current knowledge, incorrect application of the classification regulations has led to the incorrect classification ...