FDAFDA · Food and drugs·Recall number Z-0431-2014
Easy Diagnost Eleva Universal Fluoroscopic applications
Published December 11, 2013 · Recall initiated: October 30, 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
The delivered application software was an outdated version to the model of equipment.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Medical Systems, Inc.
- Distributor
- Nationwide Distribution including MN, NH, DE, OR, MA, TX, OH, FL, CA, WA, and SC.
- Lot
- 706050, 706083, 706088
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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