FDA-Device2012-08-22Class II
IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)
AGFA Corp.
Hazard
Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report.
Sold states
Worldwide Distribution - USA (nationwide) and Canada
Affected count
280
Manufactured in
10 S Academy St, Greenville, SC, United States
Products
IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2184-2012Don't want to check this manually?
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