Agency classClass IIOur severity:High FDA (Devices)·Z-1046-2017·Announced 2017-01-25

Merge Cardio software recalled for potential image loading errors

Merge Healthcare is recalling Merge Cardio software versions 9.0 through 10.1.2 because a specific user action may cause images to be missing, potentially leading to incorrect diagnosis or treatment.

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: The recall is classified as FDA Class II, and the hazard involves a risk of incorrect diagnosis or treatment without reported injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Merge Healthcare, Inc. is recalling Merge Cardio software, a system used to acquire, store, print, transfer, and archive clinical information including images, hemodynamic studies, and cardiology signal data. The recall covers versions 9.0 through 10.1.2, which are distributed nationwide in the United States. Approximately 188 sites potentially have the affected versions installed.

The recall is due to a software defect where, if a user selects a multi-study review before the original study has finished loading and then immediately returns to image review, not all current images may be present. This missing data could result in an incorrect treatment or diagnosis.

Healthcare facilities using the affected software versions should contact Merge Healthcare for instructions on how to resolve the issue. The source text does not specify a particular consumer action for individual patients, but clinical staff should be aware of this potential data integrity issue when reviewing studies.

The recalled product

Product: Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files…
Manufacturer: Merge Healthcare, Inc.
Category: Medical Device — Software
Hazard: software-defect
incorrect-diagnosis
Affected units: 188

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 (15)

Versions: 9.0
9.0.1
9.0.2
9.0.3
9.0.4
9.0.5
9.0.6
9.0.7
9.0.8
9.0.9
10.0
10.0.1
10.1
10.1.1
and 10.1.2

Distribution

Distributed nationwide across the United States.

Same manufacturer · Merge Healthcare, Inc.

See all →

High
Merge Healthcare Recalls PACS Workstations Due to Inaccurate Measurements
FDA (Devices) · 2026-09-02
High
Merge PACS Medical Imaging Workstation Recalled Due to Patient Data Display Error
FDA (Devices) · 2026-08-12
Severe
Merge OrthoPACS Imaging Workstation Recall for Patient Data Display Issue
FDA (Devices) · 2026-08-12
Moderate
Hemodynamic recording systems recalled over pressure sensor error during blood pressure measurement
FDA (Devices) · 2025-09-10
High
VERICIS Merge Cardio Medical Device Software Measurement Data Consistency Issue
FDA (Devices) · 2025-03-26

Same hazard · software defect