Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
466 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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- Relevantie
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Atrium Medical Corporation, 3011175548-05/08/2024-001-R, Advanta VXT and Flixene Vascular Graft
Between 27 December 2023 and 17 April 2024, Atrium Medical Corporation/Getinge received eight (8) complaints reporting that the ...
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Channel Medsystems, Inc., 3012018285.04242024.C.00001, Cerene Cryotherapy Device
Error code 003 was not listed in certain rows of the Cerene Cryotherapy Device Instructions for Use “Troubleshooting” section ...
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Gyrus ACMI, Inc. (Olympus Surgical Technologies America), QIL FY24-EMEA-36-FY24-OSTA-06, SOLTIVE SuperPulsed Laser System
As part of Olympus’ post market surveillance of Soltive Laser use, including a review of customer complaints and adverse events, ...
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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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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 Cardiovascular, LLC, 2242352-06/20/2023-003-R, ACCESSRAIL Platform and Acrobat Systems
Maquet/Getinge is initiating a voluntary Medical Device Field Safety Notice-Removal for the ACCESSRAIL Platform Standard Blade ...
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Intervascular SAS, FSN-RC041, HEMAGARD KNITTED Bifurcated grafts
Following an internal non-conformity report, a textile defect was identified within the body of an Hemagard Knitted bifurcated ...
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EUROS, FSN-FSCA-2023-02, NEMOST - Growing Domino - ø 5.5 mm
Following one customer complaints, we have noted that the locking ring on the notched rod of the NEMOST device was not tight ...
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Institut Straumann AG, FSN-ER21-0077, SCS Screw driver for Ratchet, short/long
Urgent Field Safety Notice SCS Screwdriver 046.401 (lot EHG85) and 046.402 (lot FAP78).
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BIOTECK SPA, FSCA REF: 230307, BIO-GEN/GRANULES
The falsified devices bear the name BIO-GEN® and the indication of Bioteck SpA as the manufacturer but have packaging ...