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.
FDA Recall Z-2532-2016 · Posted None
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Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2016-01-30
Date Terminated2021-05-07
Product Quantity146 sites may have the affected version for both products
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
Distribution was made to medical facilities nationwide and to one foreign medical facility in New Zealand. There was no military or government distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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