FDAFDA · Food and drugs·Recall number Z-2652-2017
IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats
Published July 5, 2017 · Recall initiated: December 22, 2016
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
A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV report, the NIV Cardio report was showing incorrect findings for Aneurysm.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- AGFA Healthcare Corp.
- Distributor
- Nationwide Distribution to NJ, NC, OH, PA, SC, TN, TX, and WI
- Lot
- Versions CV 12.2 SU3, CV 12.2 SU4, CV 12.2 SU5 and CV 12.2 SU6
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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