CLASS II ONGOING Device recall · Reported 13 Mar 2024 · FDA Enforcement Report
MRI system: Vantage Elan recalled by Canon Medical System, USA
Canon Medical System USA is recalling MRI system: Vantage Elan, distributed nationwide in the US. The recall was initiated on 29 Jan 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1249-2024
- FDA event ID
- 93874
- Recalling firm
- Canon Medical System USA, Tustin, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Jan 2024
- FDA classified
- 4 Mar 2024
- Reported
- 13 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 29 Jan 2024 | Recall initiated by company | |
| 4 Mar 2024 | Classified by FDA | +35 days |
| 13 Mar 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
MRI system: Vantage Elan, Model: MRT-2020
Where it was distributed
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.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMarylandMaineMichiganMinnesotaMissouri
Questions about this recall
Why was it 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 lots are affected?
UDI-DI: 04987670101632. Serial Number: S1F2052753
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 93874| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Vantage Titan recalled by Canon Medical System, USA | Canon Medical System USA | Other | Nationwide | |
| CLASS II | MRI system: Vantage Orian, Vantage Fortian recalled | Canon Medical System USA | Other | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Alphenix Infx-8000C/B5 recalled by Canon Medical System USA | Canon Medical System USA | Other | Nationwide |
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| Device | CLASS II | Alphenix Infx-8000C, interventional fluoroscopic x-ray system recalled | Canon Medical System USA | Device Malfunction | Nationwide |
| Device | CLASS II | Alphenix Infx-8000V, interventional fluoroscopic x-ray system recalled | Canon Medical System USA | Device Malfunction | Nationwide |
| Device | CLASS II | Alphenix Infx-8000H, interventional fluoroscopic x-ray system recalled | Canon Medical System USA | Device Malfunction | Nationwide |
Other Imaging Equipment recalls
All 2,347| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |