Date Initiated by Firm |
January 30, 2016 |
Create Date |
August 12, 2016 |
Recall Status1 |
Terminated 3 on May 07, 2021 |
Recall Number |
Z-2531-2016 |
Recall Event ID |
74734 |
510(K)Number |
K092915 K033825 K082144
|
Product Classification |
System, image processing, radiological - Product Code LLZ
|
Product |
iConnect Access used with 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 |
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 potentially have the affected versions 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
|
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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 = 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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