FDAFDA · Food and drugs·Recall number Z-2184-2012
IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)
Published August 22, 2012 · Recall initiated: July 27, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- AGFA Corp.
- Distributor
- Worldwide Distribution - USA (nationwide) and Canada
- Lot
- Model # L9M2100 - All Software versions of IMPAX CV Reporting
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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