Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
FDA Recall Z-2301-2016 · Posted None
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Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2016-01-30
Date Terminated2019-04-08
Product Quantity109 sites have the affected versions
Reason for Recall
Studies coming over via telmed were missing patient's DOB, procedure, and referring physician.
Firm Action
The recalling firm issued Urgent: Medical Device Recall letters dated 1/27/2016 and 5/26/2016. The letter informed the customer of the affected product, the nature of the issue, the potential harm involved, and actions to be taken. The firm released a fix for the issue; and, customers were asked to complete and return the enclosed form by June 17, 2016. Questions can be directed to [email protected].
Root Cause
Software design
Distribution Pattern
Worldwide Distribution -- USA, New Zealand, and United Kingdom.
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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