Merge Cardio software recalled for incorrect fetal measurement data retrieval
Merge Healthcare is recalling Merge Cardio software versions 10.0 through 10.1.2 because the software may display incorrect fetal measurements by pulling data from prior pregnancies.
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 involves a medical device software defect that could lead to incorrect clinical data (wrong fetal measurements), which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Merge Healthcare, Inc. is recalling specific versions of its Merge Cardio software. The affected versions are 10.0, 10.0.1, 10.1, 10.1.1, 10.1.1.1, and 10.1.2. The software is intended to acquire, store, print, transfer, and archive clinical information.
The recall is due to a defect where the fetal patient report automatically pulls prior measurement data for a previous fetus. Because the fetal study is based on the mother's Medical Record Number (MRN), the software may reference the wrong fetal measurements. This could result in incorrect data being displayed for the current pregnancy.
The potentially affected software is distributed to 30 sites in the states of Arizona, Connecticut, Florida, Georgia, Illinois, Indiana, Louisiana, Michigan, New York, North Carolina, Ohio, Oklahoma, Texas, and Vermont. Users of the affected software versions should contact Merge Healthcare for further instructions on how to resolve the issue.
The recalled product
- Product
- Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to acquire, store, print, transfer, and archive clinical information.
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Affected units
- 30
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 (6)
- Versions 10.0
- 10.0.1
- 10.1
- 10.1.1
- 10.1.1.1
- and 10.1.2.
Distribution
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