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U.S. Department of Health and Human Services

Class 2 Device Recall iConnect Access used with Ortho PACS software

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  Class 2 Device Recall iConnect Access used with Ortho PACS software see related information
Date Initiated by Firm January 30, 2016
Create Date August 12, 2016
Recall Status1 Terminated 3 on May 07, 2021
Recall Number Z-2532-2016
Recall Event ID 74734
510(K)Number K092915  K033825  K082144  
Product Classification System, image processing, radiological - Product Code LLZ
Product iConnect Access used with Ortho 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 Ortho PACS and iConnect Access V4.1 with Ortho PACS V5.1.2 and 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
Action The 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 Commerce 146 sites may have the affected version for both products
Distribution Distribution 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 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 = AMICAS, INC.
510(K)s with Product Code = LLZ and Original Applicant = CEDARA SOFTWARE CORP.
510(K)s with Product Code = LLZ and Original Applicant = ETRAUMA.COM CORP.
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