FDAFDA · Food and drugs·Recall number Z-1395-2015
GE Discovery MR950 MRI system
Published May 13, 2015 · Recall initiated: October 24, 2014
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 alignment lasers are missing the labels required by radiation safety regulations.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare
- Distributor
- US Distribution to the state of CA., and Internationally to Italy and Japan.
- Lot
- Model Number - Discovery MR950
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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