AGFA Recalls IMPAX CV Pediatric Echo Reporting Software Due to Defect
AGFA Corp. is recalling IMPAX CV Pediatric Echo Reporting software in South Carolina due to a known software defect in the OCR service.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text describes a software defect without reporting specific injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
AGFA Corp. is recalling one unit of IMPAX CV Pediatric Echo Reporting software, specifically the IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service. This software is used for the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography.
The recall is being conducted because of a failure to effectively install and test a hotfix to correct a known software defect within the IMPAX CV 7.8 SU3-OCR Service. The affected model is L9M21000, and the specific software versions involved are IMPAX CV 7.8 SU3/SU4.
The distribution pattern for this recall is limited to South Carolina only. Consumers and healthcare providers who have this specific software version should contact AGFA Corp. for further instructions on how to resolve the defect.
The recalled product
- Product
- IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography.
- Manufacturer
- AGFA Corp.
- Category
- Medical Device — Software
- Hazard
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 L9M21000 - Software versions: IMPAX CV 7.8 SU3/SU4 - OCR Service
Distribution
Distributed in 1 state:
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