24

Aug

2016

Cl II iConnect Access used with Merge PACS sw

0

Company: Merge Healthcare, Inc.
Date of Enforcement Report 8/24/2016
Class lI:

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.
Recall Number Z-2531-2016

REASON
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.

RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc, Hartland, WI on 1/30/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT 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.

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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