Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
3.586 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Emery Enterprise, Inc dba ITL Dental, EU FSCA 1-30-2024, ITL Dental Dental Implant System
During a MDSAP/EU MDR 2017/745 audit a template with the CE mark was put on 7 devices to be shipped - it was discovered, and the ...
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Acutronic Medical Systems AG, FSCA-24-001, fabian HFO, Therapy, +nCPAP Ventilators
Acutronic Medical Systems AG is pleased to make available the attached Addendum to the fabianTM Instructions for Use (IFU) for SW ...
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Unimax Medical Systems, Inc., FCA-EP24001, Detachable EndoRetrieval Pouch
The mechanism of the listed article number operates in a way that the tube within detaches during the removal process. If the ...
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QIAGEN GmbH, DEV-00000, EZ2 Connect MDx
Er is een probleem geïdentificeerd met het EZ2 Connect MDx-instrument. Dit probleem wordt veroorzaakt door onvoldoende ...
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Applied Medical Resources Corporation, 2027111-01/26/24-001-R, CA500, Epix UNIVERSAL CLIP APPLIER 3/BX
Applied Medical is conducting a Field Safety Corrective Action of specific lot numbers of its Epix® Universal Clip Applier due to ...
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MicroPort CRM S.r.l., CRM-SAL-2022-001, XFINE
Leads met hoge polarisatie kunnen sensor artefacten veroorzaken bij MV, wat kan leiden tot oversensing bij aansluiting op ALIZEA ...
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Medtronic, FA1326, Cobalt™ XT/Cobalt™/Crome™ ICDs and CRT-Ds
Een software-update voor de CareLink™ SmartSync™hulpmiddelmanager (SmartSync) is nu beschikbaar. Deze update voor SmartSync stemt ...
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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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Epic Systems Corporation, SLG 8588391, Regulated Decision Support Framework
In a system configured as described below, when the following workflow is performed, the system clears the Calculated Administer ...
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Olympus Medical Systems Corporation, QIL FY24-EMEA-40-FY24-OMSC-36, Single Use Electrosurgical Knife
Olympus's investigation has identified that deterioration of the cutting knife can contribute to tip breakage during use. ...