AGFA Healthcare Recalls IMPAX Cardiovascular Software Due to Incorrect Findings
AGFA Healthcare Corp. is recalling 10 units of IMPAX Cardiovascular software because it displayed incorrect aneurysm findings in NIV reports.
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 2/5 (Moderate).
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 issue involves incorrect data display rather than a direct physical hazard or reported injury, fitting the criteria for a moderate severity recall.
Plain-English summary
AGFA Healthcare Corp. is recalling 10 units of IMPAX Cardiovascular software, specifically versions CV 12.2 SU3, SU4, SU5, and SU6. The IMPAX CV Reporting module is a database and graphical user interface used to document procedure and clinical findings as structured data.
The recall was initiated because a customer experienced an issue where the NIV Cardio report was showing incorrect findings for Aneurysm when building a NIV report. The affected software was distributed nationwide to New Jersey, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, and Wisconsin.
Users of the affected software versions should contact AGFA Healthcare Corp. for further instructions on how to resolve the issue.
The recalled product
- Product
- IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats
- Manufacturer
- AGFA Healthcare Corp.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 10
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 (3)
- Versions CV 12.2 SU3
- CV 12.2 SU4
- CV 12.2 SU5 and CV 12.2 SU6
Distribution
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