FDA Device recall Z-2069-2012
IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of digital structured…
- FDA Device
- Class II
- terminated
- Published 2012-08-01
On 2012-08-01 the FDA classified a Class II recall of IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of digital structured… by Agfa, citing when users selected "Left stenosis" in the "Graft Duplex Conclusion" section in IMPAX CV Reporting Non-Invasive(NIV) module, "Right stenosis" appeared in the sentence display with….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2069-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-10 |
| Published | 2012-08-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Agfa |
| Distribution | US |
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 non-invasive vascular disease management. This webb-based application allows cardiology departments to view, edit and sign the structured reports.
Reason
When users selected "Left stenosis" in the "Graft Duplex Conclusion" section in IMPAX CV Reporting Non-Invasive(NIV) module, "Right stenosis" appeared in the sentence display within the printed representation of the report.
Identifiers
| code_info | Software Version: RM 2.03 to 2.08, NIV 1.0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2069-2012%22
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