AGFA IMPAX CV Reporting Software Recalled for Incorrect Stenosis Display
AGFA Corp. is recalling IMPAX CV Reporting software versions 2.03 to 2.08 because selecting 'Left stenosis' incorrectly displays 'Right stenosis' in printed 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 hazard involves a software display error that could lead to incorrect medical documentation, fitting the criteria for moderate severity without reported injuries.
Plain-English summary
AGFA Corp. is recalling the IMPAX CV Reporting software, specifically the Non-Invasive (NIV) module, due to a display error in the report generation process. The affected software versions are RM 2.03 through 2.08 and NIV 1.0. The recall covers six units distributed nationwide, including in Indiana, South Carolina, Ohio, and Texas.
The defect occurs when users select "Left stenosis" in the "Graft Duplex Conclusion" section of the IMPAX CV Reporting Non-Invasive module. In this instance, the text "Right stenosis" incorrectly appears in the sentence display within the printed representation of the report. This error could lead to inaccurate documentation of patient findings.
Healthcare facilities using this software should verify their version numbers and contact AGFA Corp. for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of digital structured reports for : adult catheterization and echocardiography, pediatric echocardiography, congenital heat disease, nuclear cardiology and…
- Manufacturer
- AGFA Corp.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 6
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 (2)
- Software Version: RM 2.03 to 2.08
- NIV 1.0
Distribution
Related recalls
Same manufacturer · AGFA Corp.
See all →- ModerateAGFA DX-D 100 X-Ray System Recalled for Touch Screen Malfunction
FDA (Devices) · 2014-07-30
- ModerateAGFA Recalls IMPAX CV Pediatric Echo Reporting Software Due to Defect
FDA (Devices) · 2014-06-04
- ModerateAGFA IMPAX RIS QDOC 5.8 Software Recall for Incorrect Patient Names
FDA (Devices) · 2014-02-12
- ModerateAgfa IMPAX 5.2 DB Server Software Recall for Performance Issues
FDA (Devices) · 2013-10-30
- HighAGFA DX-D 100 X-Ray System Recalled for Unintended Movement
FDA (Devices) · 2013-06-12
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateAGFA Healthcare Recalls IMPAX Cardiovascular Software Due to Incorrect Findings
FDA (Devices) · 2017-07-05
- ModerateAGFA IMPAX Cardiovascular Reporting Software Recalled for Missing Report Data
FDA (Devices) · 2012-08-22
- ModerateAGFA IMPAX CV Software Recall for Incorrect Data Transfer
FDA (Devices) · 2013-04-17
- ModerateAGFA Recalls IMPAX CV Pediatric Echo Reporting Software Due to Defect
FDA (Devices) · 2014-06-04
- ModerateAGFA Recalls IMPAX CV 7.8 SU3 Software Due to Design Error
FDA (Devices) · 2013-04-17
- ModerateAGFA IMPAX RIS QDOC 5.8 Software Recall for Incorrect Patient Names
FDA (Devices) · 2014-02-12