FDA Device recall Z-2715-2016
Merge RadSuite software
- FDA Device
- Class II
- terminated
- Published 2016-09-14
On 2016-09-14 the FDA classified a Class II recall of Merge RadSuite software by Merge Healthcare, citing 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 app….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2715-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-09 |
| Published | 2016-09-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merge Healthcare |
| Distribution | AL, MI, MO, PA, TN, TX |
Product
Merge RadSuite software. Radiological image processing system.
Reason
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.
Identifiers
| code_info | RadSuite Versions: 5.30.8, 5.35.3, 5.35.4, 5.35.5, 8.30.7.3, 8.30.7.4, 8.30.7.5, 8.30.7.7 are affected, BUT ONLY if t…RadSuite Versions: 5.30.8, 5.35.3, 5.35.4, 5.35.5, 8.30.7.3, 8.30.7.4, 8.30.7.5, 8.30.7.7 are affected, BUT ONLY if they are configured with all of the following conditions: (1) Must have IPID enabled; (2) Must use IPID morphers (3) Must Define a Defaultvalue in the IPID Morpher; (4) Must use the Aggregating Morpher; (5) Must not set OverwritelfPresent=false; and (6) Must be on an internal store (this is data that is already present on EA being stored to Radsuite, this excludes direct DICOM stores to the EA). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2715-2016%22
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