FDAFDA · Food and drugs·Recall number Z-0974-2024
Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
Published February 14, 2024 · Recall initiated: January 6, 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
Magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be attracted to MRI systems if the wheels are in the magnetic field.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips North America
- Distributor
- Worldwide - US Nationwide distribution in the states of FL and NY. The countries of Denmark, Norway, and Sweden.
- Lot
- UDI-DI 00884838088115 Ingenia Serial number / Accessory Serial Number 45294 100029 45294 100030
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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