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U.S. Department of Health and Human Services

Class 2 Device Recall Merge iConnect Enterprise Archive

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  Class 2 Device Recall Merge iConnect Enterprise Archive see related information
Date Initiated by Firm April 04, 2016
Create Date March 29, 2017
Recall Status1 Terminated 3 on April 10, 2020
Recall Number Z-1697-2017
Recall Event ID 76851
Product Classification Device, digital image storage, radiological - Product Code LMB
Product iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data
Code Information Versions 8.30, 8.30.2, 8.40.0, 8.40.1, 8.40.2, 8.40.2.1, 8.40.2.2, 8.70, 8.80, 8.80.0.1, 8.80.0.2, 8.80.1.1, 8.80.2, 9.0.0, 9.0.0.1, 9.1.0, 9.1.1, 9.1.2, 9.1.2.1, 9.2.0, 9.3.0, 9.3.1, 9.4, 9.4.1, 9.4.2, 9.4.2.1, and 9.4.3.
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 study is archived but cannot be opened in iConnect Access and cannot send to PACS resulting in comparison studies not being available for physician review to determine the progression of disease.
FDA Determined
Cause 2		 Software design
Action MERGE sent an Urgent Medical Device Recall letter dated July 11, 2016, to all affected customers. The recalling firm issued a letter dated 3/28/2016 via e-mail the week of 4/4/2016. If no email address was available, the letters were issued via certified mail. A second letter dated 7/11/2016 was issued to nonresponders.
Quantity in Commerce 298 sites potentially have the affected versions (290 of those in US)
Distribution Worldwide Distribution - US (nationwide) and Internationally to Canada, Belgium, Australia, Jordan, and the UK..
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.
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