Merge Cardio software using EchoIMS — Class II medical device recall Z-1415-2017
Terminated recall by Merge Healthcare, Inc., reported 2017-03-29, distributed in CA, FL, IL, MD, MO, OH, OK, TX…. A situation can occur allowing two physicians to access the same study report in EchoIMS when launched from th
| Recall number | Z-1415-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2016-04-04 |
| Classified | 2017-03-20 |
| Reported by FDA | 2017-03-29 |
| Terminated | 2017-03-20 |
| Distributed | CA, FL, IL, MD, MO, OH, OK, TX, VT, WI |
| Quantity | 17 sites |
Product
Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.
Reason for recall
A situation can occur allowing two physicians to access the same study report in EchoIMS when launched from the Cardio Study List without receiving the read-only notification prompt.
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-1415-2017. 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.