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AGFA Corp. recalls IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPA
Recalled June 4, 2014 · FDA recall Z-1662-2014 · AGFA
Hazard
Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service. · FDA Class II
Units
One
Sold at
Distribution to SC only
Description
Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service.
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.
Manufacturer(s)
AGFA Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →