Reported Mar 26, 2025 · Ongoing
Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3,…
Merge Healthcare, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merge Healthcare, Inc. · 900 Walnut Ridge Dr · Hartland, WI · 53029-8347
Is this the product you have?
- Merge Cardio
- Model/Catalog NumberVersion 12.X
- Software Version12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2; Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management system
- Lot codes and dates
- Lot CodeSoftware versions and UDIs 12.4.1
- UDI(01)00842000101123(10)12.4.1(11)240522 12.4.2
- UDI(01)00842000101123(10)12.4.2(11)250206 12.1
- UDI
(01)00842000100928(10)12.1(11)21012212.1.1
- UDI
(01)00842000100928(10)12.1.1(11)21122012.2
- UDI
(01)00842000100065(10)12.2.0(11)22071312.3
- UDI
(01)00842000101109(10)12.3.0(11)22111412.3.1
- UDI
(01)00842000101109(10)12.3.0(11)22111412.3.2
- UDI
(01)00842000101109(10)12.3.2(11)23061212.3.3
- UDI
(01)00842000101109(10)12.3.3(11)23091312.4
- UDI
(01)00842000101123(10)12.4.0(11)23122012.4.1
- UDI
(01)00842000101123(10)12.4.1(11)24052212.4.2
- UDI(01)00842000101123(10)12.4.2(11)250206
- Amount recalled
- 253
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Why it was recalled
When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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