AGFA Corp. recalls IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (inclu

Recalled August 22, 2012 · FDA recall Z-2184-2012 · AGFA

Hazard

Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report. · FDA Class II

Units

280

Sold at

Worldwide Distribution - USA (nationwide) and Canada

Description

Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report.

Product

IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)

Manufacturer(s)

AGFA Corp.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →