Z-0614-2017Class II

Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and...

Name: Z-0614-2017 Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and...
Creator: Merge Healthcare, Inc.
Published: 2016-07-14
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2016-07-14 / Terminated / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of 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... on 2016-07-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0614-2017
Classification: Class II
Status: Terminated
Initiated: 2016-07-14
Posted: 2016-11-18
Terminated: 2018-08-30
Recalling firm: Merge Healthcare Incorporated
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.
Product code: LLZ System, Image Processing, Radiological
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).
Root cause tag: software
FDA 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 [email protected]. Customers with questions were instructed to send an email to [email protected]. 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.
Product codes and lots: RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0614-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0614-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-30	2016-11-18

Product code LLZ

K053281Class IIEvms (Enterprise Visual Medical System Software)Emageon, Inc. / cleared 2005-12-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)