Company: NAGFA Corp.
Date of Enforcement Report:6/4/2014
Class lI:
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.
Recall Number Z-1662-2014
REASON
Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service.
RECALLING FIRM/MANUFACTURER
AGFA Corp., Greenville, SC on 4/30/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
One
DISTRIBUTION
Distribution to SC only
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