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U.S. Department of Health and Human Services

Class 2 Device Recall iConnect Access

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 Class 2 Device Recall iConnect Accesssee related information
Date Initiated by FirmJanuary 30, 2016
Create DateAugust 12, 2016
Recall Status1 Terminated 3 on May 07, 2021
Recall NumberZ-2531-2016
Recall Event ID 74734
510(K)NumberK033825 K082144 K092915 
Product Classification System, image processing, radiological - Product Code LLZ
ProductiConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.
Code Information iConnect Access V4.0 or earlier with any version of Merge PACS and iConnect Access V4.1 with Merge PACS V6.5.4 or earlier
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		Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Study Demographic Edit) performed after the images were ingested in PACS.
FDA Determined
Cause 2		Software design
ActionThe recalling firm issued a letter dated 1/28/2016 via e-mail on 1/31/2016 or via certified mail if they did not have an e-mail address for the customer.
Quantity in Commerce146 sites potentially have the affected versions for both products
DistributionDistribution was made to medical facilities nationwide and to one foreign medical facility in New Zealand. There was no military or government distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LLZ
510(K)s with Product Code = LLZ
510(K)s with Product Code = LLZ
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