FDAFDA · Food and drugs·Recall number Z-0524-2014
InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Systems (USA),
Published December 25, 2013 · Recall initiated: November 26, 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
GE OEC Medical Systems Inc is recalling InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Systems (USA) due to several potential safety issues related to the use of these products.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE OEC Medical Systems, Inc
- Distributor
- Nationwide Distribution
- Lot
- Model Numbers IT2500,IT2500 Plus,IT3500, IT3500 Plus
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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