Merge Healthcare VERICIS Software Version 9.0.6/8 May Cause Inconsistent Patient
Merge Healthcare recalls VERICIS software versions 9.0.6 and 9.0.8 for potential inconsistent patient measurements when users remeasure ultrasound data or edit clinical reports. Affected units may need software updates to ensure accurate patient reports.
Lower-risk recall
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.
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What happened, in plain English
Merge Healthcare recalls specific software versions of their VERICIS cardiovascular system because inconsistent patient measurements can occur when users remeasure ultrasound data or edit clinical reports directly. This could lead to inaccurate patient reports if not corrected. Read more at govinfonow.com/recall/52792-merge-healthcare-vericis-software-version-9-0-6-8-may.
Source Summary by GovInfoNow · govinfonow.com/recall/52792-merge-healthcare-vericis-software-version-9-0-6-8-may · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1398-2025
Cite this page
“Merge Healthcare VERICIS Software Version 9.0.6/8 May Cause Inconsistent Patient.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52792-merge-healthcare-vericis-software-version-9-0-6-8-may. Based on FDA recall #Z-1398-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1398-2025%22&limit=1).
Why it’s dangerous
When users follow a specific workflow involving remeasuring ultrasound data or manually editing measurement values in clinical reports, derived measurements may not match the original measurements in the final patient report. This inconsistency could lead to inaccurate patient data being recorded.
Who’s affected
Healthcare providers using VERICIS software versions 9.0.6 and 9.0.8 for cardiovascular imaging may be affected. Clinicians who manually edit measurements or remeasure ultrasound data in these versions are most at risk.
How to tell if you have this one
Check for VERICIS software versions 9.0.6 or 9.0.8, which have model catalog numbers 88-00061-00, 88-00062-00, 88-00063-00, or 88-00054-00. These versions were sold before the implementation of UDI (Unique Device Identification).
- Brand
Merge Healthcare- Category
Medical device
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1398-2025 | VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.; The following versions were introduced prior to the implementation of UDI. Version Numbers: 9.0.6, 9.0.8, Part Numbers: 88-00061-00, 88-00062-00, 88-00063-00, 88-00054-00, 88-00064-00, | 2 |
| Z-1399-2025 | VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.; Software Versions and Part Numbers: 10.0: Part Numbers: 88-00527-00, 88-00528-00, 88-00529-00, 88-00530-00, 88-00531-00, 88-00532-00, 88-00533-00, 70-00008-00; 10.1.1.1: Part Numbers: 88-01094-00; 10.1.2: Part Numbers: 88-01074-00, 88-01075-00, 88-01076-00, 88-01077-00, 88-01078-00, 88-01079-00, 88-00781-00, 88-00803-00, 88-01080-00, 70-00473-00; 10.2.0: Part Numbers: 88-01115-00, 88-01116-00, 88-01117-00, 88-01118-00, 88-01119-00, 88-01120-00, 88-01121-00, 88-01122-00, 88-01123-00, 70-00491-00, 10.2 P2: Part Numbers: 88-01203-00 10.3 P1 UDI - (01)00842000100041(10)10.3.0.2009(11)170309 | 11 |
| Z-1400-2025 | VERICIS, Merge Cardio, Model/Catalog Number: Version 11.x, Software Version: 11.0.2, 11.0.3, 11.0.4, 11.1, 11.1.1; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.; Lot Code: Software Version Numbers and UDIs 11.0.2: UDI: (01)00842000100416(10)11.0.2.1523(11)180809; 11.0.3: UDI: (01)00842000100416(10)11.0.3.1601(11)181019; 11.0.4: UDI: (01)00842000100416(10)11.0.4(11)210207; 11.1: UDI: (01)00842000100751(10)11.1.0.1054(11)181211; 11.1.1: UDI: (01)00842000100751(10)11.1.1(11)190724 | 66 |
| Z-1401-2025 | VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.; Lot Code: Software Version Numbers and UDIs 12.0.1, UDI: (01)00842000100768(10)12.0.1(11)200107; 12.0.2, UDI: (01)00842000100768(10)12.0.2(11)201117 | 37 |
| Z-1402-2025 | 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, 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 Code: Software 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)210122; 12.1.1, UDI: (01)00842000100928(10)12.1.1(11)211220; 12.2 UDI: (01)00842000100065(10)12.2.0(11)220713; 12.3, UDI: (01)00842000101109(10)12.3.0(11)221114; 12.3.1 UDI: (01)00842000101109(10)12.3.0(11)221114; 12.3.2 UDI: (01)00842000101109(10)12.3.2(11)230612; 12.3.3 UDI: (01)00842000101109(10)12.3.3(11)230913; 12.4 UDI: (01)00842000101123(10)12.4.0(11)231220; 12.4.1 UDI: (01)00842000101123(10)12.4.1(11)240522; 12.4.2 UDI: (01)00842000101123(10)12.4.2(11)250206 | 253 |
What to do — step by step
Check Software Version
Verify your VERICIS software version by checking the model catalog numbers listed in the recall notice.
How this recall unfolded
Recall timeline
FDA published this recall 35 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1398-2025 (February 19, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1398-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.