MRI system: Vantage Elan, Model: MRT-2020
Reported: March 13, 2024 Initiated: January 29, 2024 #Z-1249-2024
Product Description
MRI system: Vantage Elan, Model: MRT-2020
Reason for Recall
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.
Details
- Recalling Firm
- Canon Medical System, USA, INC.
- Units Affected
- 1
- Distribution
- 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.
- Location
- Tustin, CA
Frequently Asked Questions
What product was recalled? ▼
MRI system: Vantage Elan, Model: MRT-2020. Recalled by Canon Medical System, USA, INC.. Units affected: 1.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 13, 2024. Severity: Moderate. Recall number: Z-1249-2024.
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