Recall Z-1069-2013— AGFA Corp.
Class II · Terminated
Class II FDA medical device recall by AGFA Corp., initiated 2013-03-15, terminated 2014-04-01. It names one FDA 510(k) clearance: K050228. 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 vascular disease management.. Reason: Software design error in IMPAX CV 7.8 SU3.
- Recalling firm
- AGFA Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-03-15
- Terminated
- 2014-04-01
- 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 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 vascular disease management.
Reason for recall
Software design error in IMPAX CV 7.8 SU3
Data sourced from openFDA. This site is unofficial and independent of the FDA.