FDA-Device2014-06-04Class II
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.
AGFA Corp.
Hazard
Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service.
Sold states
Distribution to SC only
Affected count
One
Manufactured in
10 S Academy St, Greenville, SC, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1662-2014Don't want to check this manually?
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