The letter described the Product, Issue, Potential Harm, Containment by the Customer / User, Actions by Merge, and Actions by Customers. 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.
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. eFilm Workstation with Modules can be used to communicate, process and display medical images. 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). System, image processing, radiological - Product Code LLZĮFilm Workstation with Modules is a software application that is used for viewing medical images.
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