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U.S. Department of Health and Human Services

Class 2 Device Recall RadSuite iConnect

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  Class 2 Device Recall RadSuite iConnect see related information
Date Initiated by Firm April 04, 2016
Date Posted March 10, 2017
Recall Status1 Terminated 3 on August 28, 2019
Recall Number Z-1470-2017
Recall Event ID 76654
510(K)Number K053281  
Product Classification Device, digital image storage, radiological - Product Code LMB
Product iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare.
Code Information iConnect Enterprise Archive versions 5.30.0 thru 9.4.3 and V11.0.
Recalling Firm/
Manufacturer		 Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information Contact Merge Service and Support
877-741-5369
Manufacturer Reason
for Recall		 The software produced a number of "do not route" exceptions, which may result in potential patient injury or delay in diagnosis or treatment.
FDA Determined
Cause 2		 Software design
Action Merge Healthcare sent an Urgent: Medical Device Recall letter dated March 28, 2016, via e-mail the week of April 4, 2016. If no email address was available, the letters were issued via certified mail. A second letter dated July 11, 2016, was issued to nonresponders. The letter notifies the customer of the issue and informs them a fix has been released for 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. The notification also informs the customer their response is required using the enclosed form and the return addressed envelope. The response form asks, in part, if they are interested in accepting the fix. If they decline the fix, they are asked to provide the reason why. The response was required no later than April 18, 2016. Nonresponders were issued a second letter dated July 11, 2016, asking for a response by August 2, 2016.The letter and response form contained the same information as the first letter. If the second letter results in additional unresponsive customers, a call campaign will be managed by Customer Support and documented via SalesForce. Three call attempts will made before closing the case. The recalling firm reported emails will be tracked for delivery confirmation and the letters will be tracked for delivery by USPS certified services. For further questions, please call (877) 741-5369.
Quantity in Commerce 187 sites potentially have the affected versions
Distribution USA (nationwide ) Distribution to medical facilities. Government distribution was also made. There was no foreign or military distribution.
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 = LMB and Original Applicant = EMAGEON INC.
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