AGFA IMPAX Cardiovascular Reporting Software Recalled for Missing Report Data
AGFA Corp. is recalling IMPAX Cardiovascular Reporting software because user-entered conclusions were not printed on final 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, but the defect involves missing data in a reporting tool rather than a direct physical hazard or reported injury, fitting the criteria for a moderate severity issue.
Plain-English summary
AGFA Corp. is recalling 280 units of IMPAX Cardiovascular (CV) Reporting software. This software is a reporting tool used for structured reporting and structured report outputs, including XML style sheet customization and PDF generation. The recall covers all software versions of the IMPAX CV Reporting tool, specifically model number L9M2100.
The recall was initiated because content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report. This defect means that specific user-entered data may be missing from the final documentation generated by the software.
The affected products were distributed worldwide, including nationwide in the United States and in Canada. Users of this software should verify that their reports contain all intended data and contact the manufacturer for further instructions or software updates.
The recalled product
- Product
- IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)
- Manufacturer
- AGFA Corp.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 280
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)
- Model # L9M2100 - All Software versions of IMPAX CV Reporting
Distribution
Distributed nationwide across the United States.
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