Agency classClass IIOur severity:High FDA (Devices)·Z-0729-2017·Announced 2016-12-21

Merge Cardio software recalled for potential report matching errors

Merge Healthcare is recalling Merge Cardio software versions 8.30.0 through 10.1.1 because images sent without an order may be matched to the wrong accession number.

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 harm through incorrect clinical data association, which fits the criteria for a High severity score where injury has not yet been reported.

Plain-English summary

Merge Healthcare, Inc. is recalling specific versions of Merge Cardio software, a system used to acquire, store, print, transfer, and archive clinical information including images and hemodynamic studies. The affected versions are 8.30.0, 8.30.1, 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, and 10.1.1. The recall is classified as Class II by the FDA.

The recall is due to a software defect where images sent without an order in the system may be matched with the latest order on the current patient and modality. This can result in the report being matched to the incorrect accession number, although the report remains associated with the correct patient. This error could lead to clinical information being linked to the wrong study record.

Approximately 198 sites nationwide potentially have the affected versions of the software. Healthcare facilities using Merge Cardio software should verify their version numbers and contact Merge Healthcare for instructions on updating or correcting the software to prevent potential data integrity issues.

The recalled product

Product: Merge Cardio software. 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 or optical…
Manufacturer: Merge Healthcare, Inc.
Category: Medical Device — Software
Hazard: data-integrity
mis-labeling
Affected units: 198

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 (16)

Versions: 8.30.0
8.30.1
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
and 10.1.1

Distribution

Distributed nationwide across the United States.

Same manufacturer · Merge Healthcare, Inc.

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Same hazard · data integrity