Company:AGFA Corp. .
Date of Enforcement Report 8/22/12
Class ll:
PRODUCT
IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF) All software versions.
Recall Number Z-2184-2012
REASON
Content entered into the “Conclusions” free text box on the Report Writer screen was not represented on the final printed report.
RECALLING FIRM/MANUFACTURER
AGFA Corp. Greenville, SC on 7/27/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
280 units
DISTRIBUTION
Nationwide and Canada
___________________________________
