Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
4.012 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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FSN-PR130017, Drägerwerk AG & Co. KGaA, Oxylog 3000 plus
During the course of our global market surveillance activities, we have become aware of instances where emergency and transport ...
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FSN-2023-001, Xiros Ltd., Suture/needle passer
Xiros has received feedback that there have been a small number of instances where the CC-Hook instrument has deformed during ...
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FSN-FA 23021, Beckman Coulter, Inc., DxI 9000 Access Immunoassay Analyzer
Beckman Coulter heeft vastgesteld dat de hierboven vermelde softwareversie van de DxI 9000 Access-immunoassay-analyser het aantal ...
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FSN-CAPA-00005233 Abbott Diagnostics Technologies AS Alere Afinion 2 Afinion 2
Abbott has identified an issue related to overheating of Afinion 2 instruments with software version ≤ 21.13.
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FSN-01/2023, EUREKA SRL LAB DIVISION, Noradrenalina IVD, calibrator and control
A thorough examination at customer site of the calibrator performance showed that the Noradrenaline values were overestimated. ...
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FSN-PR6, Altomed Limited, Damato Ruthenium Plaque Template
Our international distributor informed us of a complaint they received from one of their customers. The CIB template (REF ...
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FSN-CI 3028397, QIAGEN GmbH, QIAstat-Dx® Respiratory SARS-CoV-2 Panel
Deze dringende veiligheidsmededeling dient om u erover te informeren dat QIAGEN heeft vastgesteld dat bepaalde partijen van de ...
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B.Braun Melsungen AG, FSCA-2023-05-30, PROSET INTRAFIX SAFESET
Tijdens kwaliteitsonderzoek is vastgesteld dat een deel van bovengenoemde artikel/charge combinatie mogelijk in verband kan ...
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Olympus Medical Systems Corporation, QIL FY24-EMEA-03-FY23-OMTA-35-HX-202-LRUR, SINGLE USE REPOSITIONABLE CLIP HX-202LR.UR
Olympus has become aware of increased complaints on clip deployment occurring during clinical procedures, leading to hazardous ...
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Lowenstein Medical Technology GmbH Co. KG, FSN-2023-01, LM150TD
If changes are made to the linking of accessories by changing products or adding accessories, a new circuit test is required to ...