Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
1.874 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Microbiologics, Inc., Recall 2025001, Helix Elite Inactivated QC Sets and Panels
Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted ...
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IntersurgicaL Ltd., 464552, Anaesthesia breathing circuits, reusable
We have received some reports of the extendable expiratory gas tubing disconnecting from the system T-piece as shown below, due ...
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Chromsystems Instruments & Chemicals GmbH, FSN 1-2025, MassTox® Antimycotic Drugs/EXTENDED Cali/Con
We have new data from stability tests that cannot confirm our previous information regarding the storage life of calibrator and ...
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Medtronic, Inc., FA1471, Torqr™ Diagnostic Catheters
Products associated with the models listed above have incorrect model and lot numbers on the outer box labeling. The inner pouch ...
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Biomet France, ZFA-2024-00248, Optipac® Vacuum mixing system
Biomet France is conducting a medical device Field Safety Corrective Action (correction) for certain Optipac products due to an ...
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Medtronic, Inc., FA1470, DLP Aortic Root Cannula with Flow-Guard, DLP Aortic Root Cannula with Flow-Guard Introducer, MiAR Aortic Root Cannula with Flow-Guard
Tijdens het productieproces werd onverwacht los materiaal aangetroffen in de mannelijke luer-aansluiting die in de ...
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Brainlab AG, CAPA-20250117-002791, Multidisciplinary medical image management SW
Wij schrijven u ter informatie van een mogelijk veiligheidsprobleem bij het gebruik van Brainlab Origin Data Management (ODM) ...
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Rocket Medical PLC, CUST-OCC824/829 (NVFSN-08), Rocket Thoracentesis Catheter 6FG & 8FG
Rocket Medical PLC has identified a manufacturing issue affecting devices from the lot(s) listed in Table 1. During the ...
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Biomet UK Ltd, ZFA-2024-00261, G7® Acetabular System - Bispherical Cup
Component loosening is a contributing factor for the reported revision cases. Since August 2020, a total of 28 product complaints ...
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Maquet Cardiopulmonary GmbH, 1186064, Heater-Cooler Unit HCU 40 High.Low Voltage
The manufacturer became aware of this issue in course of 37 complaints. While 35 earlier complaints were detected by visual ...