CLASS II ONGOING Device recall · Reported 26 Mar 2025 · FDA Enforcement Report
Vericis, Merge Cardio recalled by Merge Healthcare
Merge Healthcare is recalling Vericis, Merge Cardio. The recall was initiated on 19 Feb 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1398-2025
- FDA event ID
- 96344
- Recalling firm
- Merge Healthcare, Hartland, WI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Feb 2025
- FDA classified
- 20 Mar 2025
- Reported
- 26 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 19 Feb 2025 | Recall initiated by company | |
| 20 Mar 2025 | Classified by FDA | +29 days |
| 26 Mar 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for 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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
US
Questions about this recall
Why was it 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.
Which lots are affected?
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,
Where was it sold?
US
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 96344More recalls from Merge Healthcare
All 96| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Merge OrthoPACS, medical imaging diagnostic workstation recalled | Merge Healthcare | Other | Nationwide |
| Device | CLASS II | Merge PACS, medical imaging diagnostic workstation recalled | Merge Healthcare | Other | Nationwide |
| Device | CLASS II | The Merge Hemo recalled by Merge Healthcare | Merge Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Vericis, Merge Cardio recalled by Merge Healthcare | Merge Healthcare | Device Malfunction | WI |
Other Heart & Vascular Devices recalls
All 6,217| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Pipeline Flex Embolization Device with Shield Technology recalled | Micro Therapeutics | Labeling Errors | Nationwide |
| Device | CLASS II | System (RED 62 Reperfusion Catheter) recalled by Penumbra | Penumbra | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |