Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
465 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Megadyne Medical Products, Inc., 2334283 - MEGA SOFT Patient Return Electrodes, MEGADYNE™ MEGA SOFT™ UNIVERSAL AND UNIVERSAL PLUS REUSABLE PATIENT RETURN ELECTRODES
Megadyne Medical Products, Inc. (“Megadyne”) has received reports of patient burns identified after surgical procedures in which ...
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Covidien IIc, Surgilon Braided Nylon and Sofsilk Wax.silicone Coated Braided Silk
Medtronic heeft vastgesteld dat bepaalde partijen van de Surgilon gevlochten nylon hechtdraad en Sofsilk gevlochten zijden ...
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KARL STORZ SE & Co. KG-23-0015, BEYER Antrum Punch, Antrum Punch, Sphenoid Punch, Sphenoid Punch, Sphenoid Punch, Galea Spring Hook, Uvula Retractor, Optical Biopsy and Grasping Forceps, Grasping Forceps, Optical Scissor, Working Insert with steering lever
It was found that there is not insufficient evidence to show that the reprocessing method of the products was adequately ...
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Medtronic, FA1324, Neuroscience CST StealthStation S7 Cranial Software v3.1.4
Medtronic identified two software anomalies in StealthStation™ Cranial Version 3.1.4 software that can occur under specific ...
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Medtronic Navigation Inc., FA1384, Pin, 9733235/9733236, 100MM/150MM, Sterile, Perc Ref
Medtronic is zich ervan bewust geworden dat bepaalde partijen percutane pennen (zie Tabel 1) een kruispen bevatten waardoor de ...
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Gyrus ACMI, Inc. (Olympus Surgical Technologies America), QIL FY24-EMEA-32-FY24-OSTA-12, SOLTIVE Single-use Laser Fibers
Olympus conducted an internal review of the SOLTIVE Single-use Fibers and identified inconsistencies in the IFU. Olympus is ...
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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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Covidien llc, FA1383, Valleylab™ FT10 FT Series Energy Platform
Tijdens het onderzoeken van dit probleem hebben we gezien dat het Valleylab™ FT10 Energy Platform met softwareversies 4.0.1, ...
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Intuitive Surgical, Inc., ISIFA2022-14-C Expansion, a Vinci Xi and da Vinci X Surgical System
This Field Safety Notice is to notify you that a population of the da Vinci X and Xi system instrument arms (USMs) have ...
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ALTATEC GmbH, 6189928, Knochenprofilfräser
A physical examination of item number i5003.3350 revealed the sleeve is too tight to pass the profiler over the corresponding ...