FDAFDA · Food and drugs·Recall number Z-1662-2014
IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography.
Published June 4, 2014 · Recall initiated: April 30, 2014
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
Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- AGFA Corp.
- Distributor
- Distribution to SC only
- Lot
- Model L9M21000 - Software versions: IMPAX CV 7.8 SU3/SU4 - OCR Service
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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