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U.S. Department of Health and Human Services

Class 2 Device Recall RadSuite

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  Class 2 Device Recall RadSuite see related information
Date Initiated by Firm January 30, 2016
Create Date August 29, 2016
Recall Status1 Terminated 3 on October 15, 2019
Recall Number Z-2685-2016
Recall Event ID 74924
510(K)Number K053281  
Product Classification System, image processing, radiological - Product Code LLZ
Product RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.

RadSuite provides a means to distribute, display, and store diagnostic-quality medical images in electronic format.
Code Information Versions V8.30.6,,, and
Recalling Firm/
Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information Contact Carol Nakagawa
800-724-5970 Ext. 8027
Manufacturer Reason
for Recall
Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite.
FDA Determined
Cause 2
Software design
Action The firm, Merge, sent an "URGENT: MEDICAL DEVICE RECALL" letters dated 1/29/2016 and 5/25/2016 via e-mail or via certified mail if they did not have an e-mail address for the customers. The letters described the product, problem and actions to be taken. The customers were instructed to do the following: you must discontinue using the affected version of RadSuite or iConnect Enterprise Archive with GE AW Workstation; use the workaround listed in the letter; complete and return the enclosed form no later than June 17, 2016; ensure that all users of the product are provided with the notification; if you have further distributed this product, please identify your customers and notify them at once of this product recall Merge has a released fix available for this issue. If you have any additional questions, please send an email to recall@merge.com or call 800-724-5970 ext 8027.
Quantity in Commerce 96 sites potentially have the affected versions for both products
Distribution US Distribution to: CO and OK.
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.