Merge Healthcare, Inc.: 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.

Recall number

Z-0614-2017

Recalling firm

Merge Healthcare, Inc.

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.

Status

Terminated

Initiated

2016-07-14

Posted

not on file

Terminated

2018-08-30

Reason

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).

Root 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

29

Distribution

Nationwide Distribution including AL, CA, FL,IN, MI, MO, NY, PA, TN, and WI.

Lot, serial or model codes

RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31

510(k) numbers

["K053281"]

PMA numbers

not on file

Product code

LLZ

Firm FEI

1000116130

Firm city

Hartland

Firm state

WI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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