The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1399-2025·Announced 2025-03-26

VERICIS Merge Cardio may display inconsistent measurement data in clinical reports

The VERICIS Merge Cardio system may display inconsistent cardiovascular measurements in patient reports when specific workflows are used. This could affect clinical decisions based on the reported data.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall affecting a medical device used to generate clinical reports. While no illnesses or injuries have been reported, this represents a risk-of-harm product where data integrity issues could potentially impact clinical decision-making, meeting the criterion for High severity.

Plain-English summary

The FDA is recalling certain versions of Merge Healthcare's VERICIS Merge Cardio software, an integrated cardiovascular information system (PACS) used for managing cardiac imaging and reports. The recall affects software versions 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2, and 10.3, distributed to approximately 11 healthcare facilities in the United States.

The issue occurs when users follow a specific, less typical workflow in which they remeasure using an ultrasound device or manually edit primitive or derived measurement values directly in Clinical Reporting. When this occurs, derived measurements may become inconsistent with the associated primitive measurements in the final patient report.

Cardiovascular measurements are critical for clinical decision-making. Inconsistencies between primitive and derived measurements in patient reports could affect the accuracy of clinical decisions based on that data.

The recalled product

Product
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.
Manufacturer
Merge Healthcare, Inc.
Category
Medical Device — Cardiovascular Information System
Hazard
Affected units
11

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 5 recalled by Merge Healthcare, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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