Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
524 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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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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Medos International SARL, 2350411-Cerebase Guide Sheath Distal Cracking, CEREBASE DA Guide Sheath
Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may ...
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Maquet Cardiopulmonary GmbH, 782698, BS 3/8x3/32 L1.7
Since a label change in 2021, a label template with a Unique Device Identifier (UDI) was used for the type label attached to the ...
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B.Braun Melsungen AG, FSCA-2024-01-31, Original Perfusor® Line
Tijdens onze post-market surveillance-activiteiten hebben we het risico vastgesteld dat de mannelijke Luer-connectoren van de ...
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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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Update - Philips Medical Systems Nederland BV, 2023-IGT-BST-005, Philips Azurion
Philips heeft een mogelijk probleem vastgesteld waardoor het systeem continu opnieuw wordt opgestart (herstart-loop). Dit gebeurt ...
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Parker Laboratories, Inc, 2212018-01/17/2024-001-R, Tensive Conductive Adhesive Gel
Parker Laboratories, Inc. is conducting a voluntary recall of the above product. The reason for this recall is the viscosity of ...
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Maquet Cardiopulmonary GmbH, 946521, H 31471#Hemoconcentrator Set BC 140 / H 15981#Set BC 140 Plus
The component "Hemoconcentrator" was assembled into the finished product (Hemoconcentrator tubing set) after its shelf-life had ...
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B. Braun Melsungen AG, FSCA-VS-2023-01, Invasive blood pressure transducer set
As users already know, prolonged contact with organic solvents (spray disinfectants) can promote the formation of stress cracks ...
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Siemens Healthcare GmbH, AX010/23/S (FSCA), AX038/23/S (FSN), Sensis
If the Sensis documentation functionality is used it may happen that during adding once-per-study reporting events (Type 1 ...