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U.S. Department of Health and Human Services

Class 2 Device Recall RadSuite software

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  Class 2 Device Recall RadSuite software see related information
Date Initiated by Firm May 06, 2013
Create Date September 14, 2016
Recall Status1 Terminated 3 on July 26, 2019
Recall Number Z-2796-2016
Recall Event ID 74815
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.
Code Information This potential patient safety issue is only present in the following versions when a reverse workflow is used: 2004-R6.x, 5.10.x, 5.20, 5.25, 5.30.1, 5.30.2, 5.30.2 SB0344, 5.30.3, 5.30.4, 5.30.4 HF0418E, 5.30.5, 5.30.5 HF0404E, 5.30.5 HF0413E, 5.30.5 HF390E, 5.30.5 SB0368, 5.30.6, 5.30.6 HF0405E, 5.30.6 HF0406E, 5.30.7, 5.30.7 HF0429E, 5.30.7 HF0441E, 5.30.7 HF0446E, 5.30.7 HF0470E, 5.30.7 HF0473E, 5.30.8, 5.30.8 HF0477E, 5.30.8 HF0490E, 5.30.8 HF0495 SB0508E, 5.30.8 HF0495E, 5.30.8 HF0495E SB504E, 5.30.8 HF0550, 5.30.8 SB0485E, 5.30.8 SB0486E, 5.30.X SB0381E, 5.35.1, 5.35.1 HF0487E, 5.35.1 HF0489E, 5.35.2, 5.35.3, 5.35.4, 5.35.4 HF0513, 5.35.4 HF0518, 5.35.4 HF0528, 5.35.4 HF0531, 5.35.4 HF0535, 5.35.4 HF0546, 8.30.0.  NOTE: The standard workflow is not impacted.  . 
Recalling Firm/
Manufacturer		 Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information Contact
800-724-5970 Ext. 8027
Manufacturer Reason
for Recall		 Multiple studies were missing at a customer location that never made it to the archive before watermarking
FDA Determined
Cause 2		 Software design
Action The recalling firm first issued a letter via email dated May 6, 2013. A letter dated January 28, 2016, was also issued via email. Both letters informed the customer a software upgrade was available and of the issue and makes recommendations about using the software. They are also informed an upgrade is available to correct the issue. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. In addition, the customer is requested to call Customer Service or send them an email to schedule the upgrade. If the customer chooses not to upgrade, they are requested to complete the attached form or go online and complete it. For further questions please call (800) 724-5970 Ext. 8027.
Quantity in Commerce 45 sites potentially have the affected versions
Distribution Distribution was nationwide to medical facilities. Government distribution was made to LA 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.
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