Merge Cardio software recall due to patient data display error
Merge Healthcare is recalling Merge Cardio software versions with IPID because the system may display images from different patients as if they belong to the same individual.
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 medical device software defect that could lead to misdiagnosis or treatment errors, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Merge Healthcare, Inc. is recalling Merge Cardio software versions 8.30 through 10.1 that include the Issuer of Patient ID (IPID) feature. The recall is due to a software defect where the system may display study lists and images from different patients as though they belong to the same patient if those patients share the same first name, last name, and medical record number.
The affected software was distributed to medical facilities in Georgia, Illinois, Maryland, Michigan, Missouri, Ohio, Tennessee, and Vermont. There was no foreign, government, or military distribution. Sixteen sites were originally identified as potentially having the affected versions.
Healthcare facilities using the affected software should contact Merge Healthcare for instructions on how to resolve the issue. Patients who may have been affected by the data display error should consult their healthcare providers to verify the accuracy of their medical records and imaging studies.
The recalled product
- Product
- Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Affected units
- 16
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 (13)
- Versions 8.30
- 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
- 10.0
- 10.0.1
- and 10.1 with Issuer of Patient ID (IPID)
Distribution
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