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.
What this means for you
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 characte
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- 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.
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