AGFA IMPAX CV Reporting Software Recalled for Incorrect Stenosis Display
AGFA Corp. is recalling IMPAX CV Reporting software versions 2.03 to 2.08 because selecting 'Left stenosis' incorrectly displays 'Right stenosis' in printed reports.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a software display error that could lead to incorrect medical documentation, fitting the criteria for moderate severity without reported injuries.
Plain-English summary
AGFA Corp. is recalling the IMPAX CV Reporting software, specifically the Non-Invasive (NIV) module, due to a display error in the report generation process. The affected software versions are RM 2.03 through 2.08 and NIV 1.0. The recall covers six units distributed nationwide, including in Indiana, South Carolina, Ohio, and Texas.
The defect occurs when users select "Left stenosis" in the "Graft Duplex Conclusion" section of the IMPAX CV Reporting Non-Invasive module. In this instance, the text "Right stenosis" incorrectly appears in the sentence display within the printed representation of the report. This error could lead to inaccurate documentation of patient findings.
Healthcare facilities using this software should verify their version numbers and contact AGFA Corp. for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of digital structured reports for : adult catheterization and echocardiography, pediatric echocardiography, congenital heat disease, nuclear cardiology and non
- Manufacturer
- AGFA Corp.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 6
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 (2)
- Software Version: RM 2.03 to 2.08
- NIV 1.0
Distribution
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