FDAFDA · Food and drugs·Recall number Z-0903-2019
SmartPath to dStream for XR and 3.0T, Model Number 781270. Nuclear Magnetic Resonance Imaging System
Published March 6, 2019 · Recall initiated: December 21, 2018
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
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Medical Systems Nederlands
- Distributor
- U.S. Nationwide distribution.
- Lot
- All systems
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Netherlands
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