Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
437 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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MAQUET Cardiovascular LLC, 2242352-10/31/2023-006-R, Acrobat-i Vacuum Positioner System
Maquet/Getinge received thirty-two (32) complaints between January 1, 2020, and September 19, 2023, reporting issues related to ...
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Maquet Cardiopulmonary GmbH, 881842, Cardiohelp-i
A noticeable high number of breaks in the insulation sheath and a shielding breach of the venous probe connection cable was ...
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Medtronic, Inc, FA1368, LINQ II Insertable Cardiac Monitor
Een populatie van LINQ II insertable cardiac monitors (ICM) onderging een fabricageproces waardoor vocht de elektrodeprestaties ...
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Maquet Cardiopulmonary GmbH, 879551, CARDIOHELP-i
The IFU of the CARDIOHELP system states incorrect factory settings. The device itself is working as intended and the error only ...
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Edwards Lifesciences LLC, FCA 181, Acumen IQ Sensor, FloTrac Sensor, TruWave DPT
Het onderzoek bracht een fabricageprobleem aan het licht dat een mogelijke verstopping in bepaalde druksets en sensoren ...
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Maquet Cardiopulmonary GmbH, 881841, Cardiohelp-i
The root cause of the improper contact originates in an incorrect drawing of the production tool in question, resulting in an ...
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HeartWare Inc., FA1372, HeartWare™ Ventricular Assist Device (HVAD™) System
Tot 15 augustus 2023 heeft Medtronic acht (8) klachten ontvangen over onvoldoende informatie over de levensduur in de ...
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Bort GmbH, 1013xxx-RR, Bort X-Walker
Due to a material and design issue, the blue connecting bolts which attach the fasteners and D-rings to the gray walker shell may ...
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Atrium Medical Corporation, 3011175548-09/13/2023-001-R, Advanta V12 Covered Stent System
Atrium/Getinge is initiating a voluntary Medical Device recall/removal for the Advanta V12 covered stent system due to an ...
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Philips Goldway (Shenzhen) Industrial Inc., 2023-CC-EC-026-IR, Philips HeartStart Intrepid Monitor/Defibrillator
The current HeartStart Intrepid Service Manual does not detail IEC Class I electrical safety test verification methods. The lack ...