Merge Healthcare Recalls Merge Cardio Software Due to Data Integrity Issues
Merge Healthcare is recalling Merge Cardio software versions 9.0 through 9.0.8 because users can merge device files with confirmed reports, potentially adding unverified information.
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 involves a risk-of-harm product (medical software) where the defect could lead to incorrect clinical information, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Merge Healthcare, Inc. is recalling Merge Cardio software versions 9.0, 9.0.1, 9.0.2, 9.0.3, 9.0.4, 9.0.5, 9.0.6, 9.0.7, and 9.0.8. The software is intended to acquire, store, print, transfer, and archive clinical information, including images, hemodynamic studies, and cardiology signal data.
The recall was initiated because users can merge a device import file with an image study that already has a confirmed report. This action may result in including information in the record that was not present at the time of physician interpretation, potentially compromising the integrity of the clinical data.
The recall is classified as Class II by the FDA. Approximately 89 sites potentially have the affected software, which was distributed nationwide in the United States. Users should contact Merge Healthcare for further instructions on how to address the software defect.
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
- Affected units
- 89
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 (9)
- Versions 9.0
- 9.0.1
- 9.0.2
- 9.0.3
- 9.0.4
- 9.0.5
- 9.0.6
- 9.0.7
- and 9.0.8
Distribution
Distributed nationwide across the United States.
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