Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31. Advanced Visualization (Image Viewing) includes: Full featured 2D imaging, 3D surface and volume rendering, Real-time Multi-Planar Reformatting (MPR), Real-time oblique imaging, Integrated image fusion, JPEG2000-based Adaptive Bandwidth Streaming, JPEG and Key Image Note export, Presentation States, Annotation and measurement tools, Automated linking, Display protocols, Enterprise Worklist, prior study management, softcopy viewing of digital mammography images provided that only 5 MP monitors with a cleared 510(k) are used and that digitized secondary captures of these images are not viewed for assisting in diagnosis, utilization of thirdparty electronic orthopedic templates, the display of Standard Uptake Value, recording voice reports using third party, plug-in software, and user configurable settings for viewing digital medical images and corresponding data The application provides a means to distribute, display, and store diagnostic-quality medical images in electronic format. The system displays traditional 2D and reconstructed 3D radiological images using Webenabled viewers over both local and wide area networks. The application provides workflow integration capabilities for health care enterprises, wherein: Radiologists can view, annotate, and tag studies as diagnostically Read. Referring physicians can view patient images and radiologists annotations. Tertiary care physicians, medical technologists, and information technology professionals can receive patient records.
FDA Recall Z-0614-2017 · Posted None
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Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2016-07-14
Date Terminated2018-08-30
Product Quantity29
Reason for Recall
It was reported by a customer that RadSuite images are not appearing as readable images.
This product malfunction has the potential to result in delay in care and a possible re-exposure of the patient to radiation (x-ray).
Firm Action
Merge sent an Urgent Medical Device Recall letter dated October 19, 2016,(Recall #2016-075) to all affected customers. Initially, before it was considered a recall, the firm provided customers with a software upgrade to fix the issue. The letter described the Product, Issue, Potential Harm, Containment by the Customer/User, Action by Merge and Actions by Customers. Requested consignees to complete and return the response form. For questions email [email protected]. Customers with questions were instructed to send an email to [email protected].
For questions regarding this recall call 262-367-0700.
Root Cause
Software design
Distribution Pattern
Nationwide Distribution including AL, CA, FL,IN, MI, MO, NY, PA, TN, and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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