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Merge Healthcare, Inc. recalls iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, rep
Recalled August 24, 2016 · FDA recall Z-2532-2016 · Merge Healthcare
Hazard
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 Class II
Units
146 sites may have the affected version for both products
Sold at
Distribution was made to medical facilities nationwide and to one foreign medical facility in New Zealand. There was no military or government distribution.
Description
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.
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.
Manufacturer(s)
Merge Healthcare, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →