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U.S. Department of Health and Human Services

Class 2 Device Recall Merge RadSuite software

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  Class 2 Device Recall Merge RadSuite software see related information
Date Initiated by Firm April 09, 2015
Date Posted September 02, 2016
Recall Status1 Terminated 3 on August 24, 2017
Recall Number Z-2715-2016
Recall Event ID 74853
510(K)Number K053281  
Product Classification System, image processing, radiological - Product Code LLZ
Product Merge RadSuite software. Radiological image processing system.
Code Information RadSuite Versions: 5.30.8, 5.35.3, 5.35.4, 5.35.5, 8.30.7.3, 8.30.7.4, 8.30.7.5, 8.30.7.7 are affected, BUT ONLY if they are configured with all of the following conditions: (1) Must have IPID enabled;  (2) Must use IPID morphers  (3) Must Define a Defaultvalue in the IPID Morpher;  (4) Must use the Aggregating Morpher;  (5) Must not set OverwritelfPresent=false; and  (6) Must be on an internal store (this is data that is already present on EA being stored to Radsuite, this excludes direct DICOM stores to the EA). 
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		 When RadSuite is used with IPID (Issuer of Patient ID) as a part of the "Patient Identifier," it is possible in some circumstances that the demographics of one patient will be applied to a study or studies for another patient.
FDA Determined
Cause 2		 Software design
Action The recalling firm issued letters dated 4/3/2015 via email on 4/9/2015 notifying the customer of the issues.
Quantity in Commerce 10 sites have the affected software that is configured with the specific conditions listed in Code Information
Distribution Distribution was made to medical facilities in AL, MI, MO, PA, TN, and TX.
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.
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