AGFA IMPAX CV Software Recall for Incorrect Data Transfer
AGFA Corp. is recalling 26 units of IMPAX CV software because baseline pulmonary capillary wedge pressure values were not correctly transferring into hospital electronic health records.
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 source text does not report any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
AGFA Corp. is recalling 26 units of the IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting software. The recall involves software versions 7.8, 7.8 SU1, 7.8 SU2, 7.8 SU3, and 7.8 SU2.5 with the IMPAX CV Outbound Report Stylesheet 7.8_HL. The affected software facilitates digital reports for catheterization, echocardiography, and congenital heart disease.
The recall was initiated because baseline pulmonary capillary wedge (PCW) pressure values from the IMPAX CV Reporting Cardiac Catheterization module were not correctly transferring into the hospital's electronic health record (EHR) system. This defect could result in incomplete or inaccurate data within the patient's medical record.
The affected units were distributed nationwide, including in the states of Alaska, Georgia, Illinois, Kentucky, Massachusetts, New York, North Carolina, Rhode Island, South Carolina, Texas, and Virginia. Healthcare facilities using this software should contact AGFA Corp. for further instructions on how to resolve the data transfer issue.
The recalled product
- Product
- IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.
- Manufacturer
- AGFA Corp.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 26
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 (4)
- Model # L9M21000. Software versions: IMPAX CV 7.8
- 7.8 SU1
- 7.8 SU2 and 7.8 SU3
- IMPAX CV 7.8 SU2.5 with IMPAX CV Outbound Report Stylesheet 7.8_HL
Distribution
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