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 V
Summary
The FDA issued a Class II for VERICIS, Merge Cardio, Model/Catalog Number: Version 11.x, Software Version: 11. by Merge Healthcare, Inc.. Reason: When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measur.
Details
Source
Device Recall
External ID
Z-1400-2025
Action Date
2025-03-26
Status
Ongoing
Category
device
Product Description
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 Info: 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
Quantity Affected: 66
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.
Distribution
US
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-19
Company
Hartland, WI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 195 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Merge Healthcare, Inc. has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Merge Healthcare, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Merge Healthcare, Inc. have FDA actions?
Merge Healthcare, Inc. has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1400-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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