Vericis recall
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…
Why was Vericis 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- 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…
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 66
- Distribution
- US
- Recall date
- March 26, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)