FDAFDA · Food and drugs·Recall number Z-0461-2023
Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144
Published December 14, 2022 · Recall initiated: November 22, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips North America Llc
- Distributor
- US Nationwide.
- Lot
- Model 782118: Serial Numbers: Included in Letter but No Devices Distributed in the US. Model Number 782132: Serial Numbers: Included in Letter but No Devices Distributed in the US. Model Number 782144: Serial Numbers: Included in Letter but No Devices Distributed in the US.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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