AGFA Recalls IMPAX CV 7.8 SU3 Software Due to Design Error
AGFA Corp. is recalling IMPAX CV 7.8 SU3 software due to a design error. The product was distributed in Florida and Kentucky.
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. No specific injuries or illnesses are reported in the source text, placing it in the Moderate category.
Plain-English summary
AGFA Corp. is recalling two units of the IMPAX CV 7.8 SU3 - OCR Service software. The recall is due to a software design error. The IMPAX CV Reporting component is used to create digital structured reports for various cardiology and vascular disease management procedures.
The affected software was distributed in the states of Florida and Kentucky. The specific software version is IMPAX CR 7.8 SU3 Optical Character Recognition (OCR) Service.
Consumers and healthcare facilities should contact AGFA Corp. for further instructions regarding the recall and potential replacement or repair of the software.
The recalled product
- Product
- IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive…
- Manufacturer
- AGFA Corp.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 2
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)
- Softwaer version: IMPAX CR 7.8 SU3 Optical Character Recognition (OCR) Service
Distribution
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