Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
528 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Remote Diagnostic, FA-009, Tempus Pro
Samenvatting: In de brief staat dat we een intermitterende softwarefout hebben ontdekt als onderdeel van een interne ...
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Remote Diagnostic Technologies Ltd., Tempus Pro
An issue has been identified with the Tempus Pro Monitor where an error may occur during video laryngoscope use with the Tempus ...
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Remote Diagnostic Technologies Ltd., 2023-CC-EC-005-IR, Tempus Pro
An issue has been identified with the Tempus Pro Monitor where an error may occur during video laryngoscope use with the Tempus ...
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Aesculap AG, FSCA 235, Synthetic vascular graft
In the cause of an internal investigation Aesculap AG became aware of a product counterfeit of the UNI Graft K DV vascular ...
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Maquet Cardiopulmonary GmbH, 946576, BE-MECC 142000#NRP pack
Maquet Cardiopulmonary GmbH (MCP) would like to inform you with this letter about a recall for the Custom Tubing Pack (CTP) ...
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Boston Scientific Corporation, 97174890-FA, POLARSHEATH Steerable Sheath
Boston Scientific has identified a tooling error in manufacturing which may have caused delamination of the inner lumen of the ...
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PendraCare International B.V., 23-001, Convey Guiding Catheter
The purpose of this letter is to notify you that PendraCare International B.V. is conducting a voluntary field action/removal for ...
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Datascope Corp., 2249723-06.02.2023-010-C, Cardiosave Intra-Aortic Balloon Pumps
Datascope Corp., a subsidiary of Getinge is initiating a voluntary Medical Device Correction for the Cardiosave Hybrid and ...
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BALT FSN 20210104_Optima Labelling Mix-Up - OPTIMA COIL SYSTEM
With the way that product label reconcilation works at Balt USA, it can reaonably be assumed that there is at least one (1) other ...
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Draeger Medical Systems PR116042 - Infinity® CentralStation SW VG2.1.2(SU1)
During the course of our global market surveillance activities, we have become aware of cases in which restarts of the lnfinity® ...