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.
___________________________________
