FDAFDA · Food and drugs·Recall number Z-1069-2013
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.
Published April 17, 2013 · Recall initiated: March 15, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Software design error in IMPAX CV 7.8 SU3
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- AGFA Corp.
- Distributor
- Distribute in the state of FL and KY
- Lot
- Softwaer version: IMPAX CR 7.8 SU3 Optical Character Recognition (OCR) Service
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States