Merge Cardio software recall due to incorrect patient data saving
Merge Healthcare is recalling Merge Cardio software versions 10.1 and 10.1.1 because reports may be saved to incorrect patient records.
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 involves a risk-of-harm product (medical software) where incorrect patient data could lead to medical errors, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for theoretical risk.
Plain-English summary
Merge Healthcare, Inc. is recalling Merge Cardio software, an image processing system. The affected versions are 10.1 and 10.1.1. The recall is due to a defect where reports can be confirmed with incorrect patient demographics, resulting in the data being saved under the wrong patient record in the Electronic Medical Record (EMR).
The affected software was distributed nationwide. Approximately 116 customers potentially have the affected versions. The source text does not specify specific dates of distribution or installation.
Healthcare facilities should contact Merge Healthcare for instructions on how to resolve the issue. The source text does not provide specific consumer instructions or a hotline number.
The recalled product
- Product
- Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Affected units
- 116
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 (1)
- Versions 10.1 and 10.1.1
Distribution
Distributed nationwide across the United States.
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