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Learn more about medical device recalls.Ģ Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.ģ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.ĥ10(K)s with Product Code = LLZ and Original Applicant = EFILM MEDICAL, INC. Efilm Workstation 3.4 Keygen Download Crack >.
The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Worldwide Distribution - US: Nationwide including DC, GU, PR and Internationally to Canada, Argentina, Armenia, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Congo, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Guatemala, hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Mauritania, Mexico, Netherlands, New Caledonia, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia and Montenegro, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Vietnam, and Yemen.ġ A record in this database is created when a firm initiates a correction or removal action. Customers with questions were instructed to send an email to in Commerce Requested consignees for a response to the notification. Advised consignees to discontinue using the product, and identify & notify all customers. eFilm Workstation allows users to have a full diagnostic quality workstation, dedicated CD/DVD burning, DICOM printing and an image review station in a low cost and high content solution that is scalable to any organization. The letter described the Product, Issue, Potential Harm, Containment by the Customer / User, Actions by Merge, and Actions by Customers. Merge eFilm Workstation is a stand-alone workstation solution to view, distribute and manage studies. Merge Healthcare sent an Urgent Medical Device Recall letter dated October 12, 2016, to all affected consignees. cal label is not displayed on the projection images after calibration is performed which should be present if the measurement is presented based on Pixel Spacing. cal (Calibration) is not displayed and measurement is not correct. Typical users of eFilm Workstation with Modules are trained medical professionals, including but not limited to radiologists, technologists and cliniciansĮFilm Workstation and eFilm Lite versions 2.1, 2.1.2, 3.0, 3.1, 3.3.5, 3.4, 4.0, 4.0.1, 4.0.2, 4.0.3 and 4.1.Ī product issues happens for RF projection images. eFilm Workstation with Modules can be integrated with an institution s existing HIS or RIS for a fully integrated electronic patient record. 3.1.10 While working with the CodeWarrior IDE, the Remote System Changed dialog. In addition, users can overlay templates on medical images to aid in preoperative planning. Users have access to various image processing and measurement tools to assist them in viewing images. Photo & Graphics tools downloads - eFilm Workstation by Merge Healthcare and many more programs are available for instant and free download. eFilm Workstation with Modules can be used to communicate, process and display medical images. Merge eFilm Workstation/eFilm Lite versions 2.1, 2.1.2, 3.0, 3.1, 3.3.5, 3.4, 4.0, 4.0.1, 4.0.2, 4.0.3 and 4.1(Picture archiving and communication system)ARTG Number. eFilm Workstation with Modules receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). SFDA urges all hospitals that have devices subjected to recall, to contact the company.System, image processing, radiological - Product Code LLZĮFilm Workstation with Modules is a software application that is used for viewing medical images. Advised consignees to discontinue using the product, and identify & notify all customers.Īthorized Representative/Importer/Distributor: cal label is not displayed on the projection images after calibration is performed which should be present if the measurement is presented based on Pixel Spacing.Ĭustomers. cal (Calibration) is not displayed and measurement is not correct. eFilm Workstation 4.2 ORS Visua Intergraph COADE TANK v2017 SP1 Coventor SEMulator3D 7.1 圆4 Geometric NestingWorks 2018 SP3.0 For SolidWorks 2018 圆4 geomodeling attributestudio v8.1 EPLAN API 2.8 Win64 Materialise 3-Matic Research&Medical 13.0 圆4 Geometric.GeomCaliper.2.5.
Reason of Field Safety Corrective Action:Ī product issues happens for RF projection images.
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