FDAFDA · Food and drugs·Recall number Z-1070-2013
IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.
Published April 17, 2013 · Recall initiated: March 15, 2013
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
Baseline pulmonary capillary wedge (PCW) pressure values from IMPAX CV Reporting Cardiac Catheterization module were not correctly transferring into the hospital's electronic health record (EHR) system.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- AGFA Corp.
- Distributor
- Nationwide Distribution including the states of AK, GA, IL, KY, MA, NY, NC, RI, SC, TX, and VA.
- Lot
- Model # L9M21000. Software versions: IMPAX CV 7.8, 7.8 SU1, 7.8 SU2 and 7.8 SU3, IMPAX CV 7.8 SU2.5 with IMPAX CV Outbound Report Stylesheet 7.8_HL
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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