FDAFDA · Food and drugs·Recall number Z-1249-2024
MRI system: Vantage Elan, Model: MRT-2020
Published March 13, 2024 · Recall initiated: January 29, 2024
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
For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety manual are lower than the correct values, which may cause a patient with an MR conditional device to feel some discomfort during the MR scan.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Canon Medical System, USA, INC.
- Distributor
- Worldwide - US Nationwide distribution including in the states of MD, IL, WV, CA, AZ, PR, CO, GA, PA, WA, UT, OK, KY, IA, IN, TN, CT, WI, OH, AL, MT, NM, TX, MO, MN, OR, ID, WY, NV, AR, FL, SD, MI, NY, NJ, KS, LA, NH, VT, MS, SC, ME and the country of DO.
- Lot
- UDI-DI: 04987670101632. Serial Number: S1F2052753
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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