Device 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.
Z-1069-2013
Product summary
- Firm
- AGFA Corp.
- Event
- Event 64654
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2
- Official record key
device-enforcement:Z-1069-2013
Official wording
Reason: Software design error in IMPAX CV 7.8 SU3
Code information: Softwaer version: IMPAX CR 7.8 SU3 Optical Character Recognition (OCR) Service
Distribution pattern: Distribute in the state of FL and KY
Derived failure modes
-
Device software or design
Software design error