DR Systems Unity PACS software, now known as Merge Unity PACS software.
FDA Recall Z-0939-2017 · Posted None
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Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2015-10-15
Date Terminated2021-04-23
Product Quantity9 sites potentially have the effected software
Reason for Recall
The software fails to associate to the correct MG image if there are two images for the same view.
Firm Action
Merge sent an Urgent : Medical Device Recall letter dated July 11, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Be aware of the following workaround: Customer I User:
Ensure both" tome" images are reviewed when more than one is captured for the same view. Merge has a released fix available for this issue.
YOUR RESPONSE TO THIS NOTIFICATION IS REQUIRED
Please reply using the enclosed form and the return addressed envelope. Your response is required no later than August 2,2016. For further questions regarding this recall please call (877) 741-5369
Root Cause
Software design
Distribution Pattern
Distribution was made to medical facilities located in MT, CA, PA, and TX.
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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