Merge RadSuite software — Class II medical device recall Z-2715-2016
Terminated recall by Merge Healthcare, Inc., reported 2016-09-14, distributed in AL, MI, MO, PA, TN, TX. When RadSuite is used with IPID (Issuer of Patient ID) as a part of the "Patient Identifier," it is possible i
| Recall number | Z-2715-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2015-04-09 |
| Classified | 2016-09-02 |
| Reported by FDA | 2016-09-14 |
| Terminated | 2017-08-24 |
| Distributed | AL, MI, MO, PA, TN, TX |
| Quantity | 10 sites |
Product
Merge RadSuite software. Radiological image processing system.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2715-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.