Device product
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.
Z-1662-2014
Product summary
- Firm
- AGFA Corp.
- Event
- Event 68211
- Status
- Terminated
- Classification
- Class II
- Quantity
- One
- Official record key
device-enforcement:Z-1662-2014
Official wording
Reason: Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service.
Code information: Model L9M21000 - Software versions: IMPAX CV 7.8 SU3/SU4 - OCR Service
Distribution pattern: Distribution to SC only
Derived failure modes
-
Device software or design
software defect