Recall Z-2069-2012— AGFA Corp.
Class II · Terminated
Class II FDA medical device recall by AGFA Corp., initiated 2012-07-10, terminated 2013-10-29. It names one FDA 510(k) clearance: K050228. 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..
- Recalling firm
- AGFA Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-07-10
- Terminated
- 2013-10-29
- Firm location
- Greenville, SC, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.