FDAFDA · Food and drugs·Recall number Z-0035-2014
IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).
Published October 30, 2013 · Recall initiated: September 19, 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
System downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at current supported levels.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- AGFA Corp.
- Distributor
- Worldwide distrbution: US(nationwide) distribution including NY and OK, and country of Canada.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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