Merge RadSuite software. Radiological image processing system.
FDA Recall Z-2715-2016 · Posted 2016-09-02
Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2015-04-09
Date Terminated2017-08-24
Product Quantity10 sites have the affected software that is configured with the specific conditions listed in Code Information
Reason for Recall
When RadSuite is used with IPID (Issuer of Patient ID) as a part of the "Patient Identifier," it is possible in some circumstances that the demographics of one patient will be applied to a study or studies for another patient.
Firm Action
The recalling firm issued letters dated 4/3/2015 via email on 4/9/2015 notifying the customer of the issues.
Root Cause
Software design
Distribution Pattern
Distribution was made to medical facilities in AL, MI, MO, PA, TN, 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.