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, 8.30.6.1, 8.30.6.2, and 8.30.6.3 |
Recalling Firm/ Manufacturer |
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
|
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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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