Class 2 Device Recall RadSuite (by Merge Healthcare)

• Date Initiated by Firm: July 14, 2016
• Create Date: November 18, 2016
• Recall Status: Terminated on August 30, 2018
• Recall Number: Z-0614-2017
• Recall Event ID: 75267
• 510(K)Number: K053281
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: 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.
• Code Information: RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31
• Recalling Firm/ Manufacturer: Merge Healthcare, Inc.; 900 Walnut Ridge Dr; Hartland WI 53029-8347
• For Additional Information Contact: 262-367-0700
• Manufacturer 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).
• FDA Determined Cause: Software design
• 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 recall@merge.com. Customers with questions were instructed to send an email to recall@merge.com. For questions regarding this recall call 262-367-0700.
• Quantity in Commerce: 29
• Distribution: Nationwide Distribution including AL, CA, FL,IN, MI, MO, NY, PA, TN, and WI.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. 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. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LLZ and Original Applicant = EMAGEON INC.