Reported Aug 22, 2012 · Terminated

IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs…

AGFA Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: AGFA Corp. · 10 S Academy St · Greenville, SC · 29601-2632

Is this the product you have?

  • IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)
Lot codes and dates
  • Model # L9M2100 - All Software versions of IMPAX CV Reporting
Amount recalled
280

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 13, 2015 · Data as of Sep 19, 5:23 PM UTC

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