Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
449 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
- Datum
- Relevantie
-
Corcym S.r.l., REC-000384, Perceval Plus Sutureless Aortic Heart Valve
Corcym ontdekte dat sommige polymeer deeltjes, afkomstig van een van de apparaten die werden gebruikt voor het ...
-
Gyrus ACMI, Inc., SG PK CUTTING FORCEPS, 5MM, 33CM. Olympus
The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.
-
Gyrus ACMI, Inc., TFL Fiber Cleaver, TFL Fiber Stripper. Olympus
Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile fiber stripper or cleaver on a ...
-
Zimmer Surgical Inc., ZFA2023-00275, Dermacarriers
As a result, the package label and the ratio text identify the product as a 3:1 ratio. However, the ridge pattern is a 1.5:1 ...
-
Lohmann & Rauscher International GmbH & Co. KG, Suprasorb A+Ag Antimicrobial Ca-Alginate Dressing
The date was incorrectly printed on the primary packaging. The sterile single packaging and the secondary packaging (for ...
-
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 ...
-
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 ...
-
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 ...
-
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 ...
-
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 ...