CLASS II ONGOING Device recall · Reported 19 Jun 2024 · FDA Enforcement Report
MRI systems: Vantage Orian Mrt-1550 (Mexl-1550) recalled
Canon Medical System USA is recalling MRI systems: Vantage Orian Mrt-1550 (Mexl-1550), Vantage Elan Mrt-2020 (Mexl-1520), distributed in 38 states. The recall was initiated on 10 May 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-2041-2024
- FDA event ID
- 94609
- Recalling firm
- Canon Medical System USA, Tustin, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 May 2024
- FDA classified
- 9 Jun 2024
- Reported
- 19 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 10 May 2024 | Recall initiated by company | |
| 9 Jun 2024 | Classified by FDA | +30 days |
| 19 Jun 2024 | Published in enforcement report | +10 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The terminal block used to secure the power supply cable for the gradient coil of the MRI system was not secured as designed, which could cause cable disconnection, which could lead to arcing, followed by melting of the cable, ignition, smoke, and fire.
Product as listed by the FDA
MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage Titan 3T MRT-3010 (MEXL-3010), Vantage Galan 3T MRT-3020 (MEXL-3020)
Where it was distributed
US: PA, SC, IA, AL, MI, AR, SD, TX, ID, KY, NY, MN, MD, OH, WI, NV, CT, AZ, IL, OK, CA, FL, GA, OR, IN, NJ, CO, MT, KS, MO, WY, VA, VT, LA, NH, WV, TN, PR
AlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMarylandMichiganMinnesotaMissouriMontana
Questions about this recall
Why was it recalled?
The terminal block used to secure the power supply cable for the gradient coil of the MRI system was not secured as designed, which could cause cable disconnection, which could lead to arcing, followed by melting of the cable, ignition, smoke, and fire.
Which lots are affected?
Model/UDI-DI/Serial Numbers: MRT-1550 (MEXL-1550)/04987670103360/POA21X2002, S5A1982001, S5B22Z2041, S5B2172018, S2C2252024, S5A20Z2009, S2C21Y2021, S2B2052010, S5B2272031, POA2262005, S5B2292036, S5B2272029, S5B2282034, S5B22Y2040, S5B2292035, S6B2252008, S5A20Z2010, POA2252004, POA2182001, S1C2152071, S5B2352047, S2C2252023, S5B2122013, S6B2262010, S2C2192020, S6B2292013, S5B2132014, S6B2322018, S5B2292038, S6B2312016, S2B2052011, S2C2162018, S4A1992013, S3A19Z2013, S3A1982009, S5B2182021, S6B2322017, S5A2092008, S6B2362019, S5B22Z2042, S6B2222005, S2B2042009, S2B20Z2015, S5B2162017, S6B2262011, S5B2272030, S6B22Z2014, S5B2282033, S8B2272009, S5A2062007, S2B2072012, S2B2072013, S6B2222006, S6B2272012, S2B2072014, S6A20Z2001, POA2272006, S5A19Z2003, S1C2142070, POA2212003, S2C2142017, S5B2362048, S2A1962005, S6B2182004, S5B2292037, S6B2252007, S5B2282032, S5B2142015, S5B2382050, S2A18Z2003, S6B2112002, S6B2382021, S1B2042051, S8B2212007, S1B2062057, S1A1922022, S2A18Z2001, S1B2092067, S1C2242080, S5B2172019, S6B2252009, S6B2372020, S2A18Z2002, S2A1942004, S2C2212022, S2C2272025, S6B2392022, S2C2162019, S2C2132016, S4B2062020, S1C2262081, PDA21Y2001, S6B22Z2015, S5B22Z2043, S5B2242027, MRT-2020 (MEXL-1520)/04987670101632/S1F18X2580, S1B1492068, S1D17Y2461, S1F2052753, S1C1722390, S1C1682336, S1E1842517, S1E1842527, S1C1672334, MRT-1504 (MEXL-1504)/04987670102400/U5B15Z2001, MRT-3010 (MEXL-3010)/04987670101649/A5D14X2032, A5C12Y2017, A5D13Y2025, A5C1412028, S7A1642006, A5D13Y2026, A5C1212009, A5C12X2016, A5G1692038, A5G1642036, A5F1562034, A5B11Y2005, A5C1262013, A5E1522033, A5G1692039, A5D14X2031, A5B1192003, A5B11Y2006, A5D1312019, A5D1362021, A5C1252012, A5C1292015, A5D13X2024, A5C1422029, A5B11Z2007, A5C1212008, MRT-3020 (MEXL-3020)/04987670102615/D5A2082005, D5A2092007, D5B2152013, S5B17X2034, D7B2182017, 5DB2152002, S5B18X2046, S5A17X2033, D5A2062003, S5A1742021, D5B2212019, D5B2192016, S5A1662001, S5C18Y2048, S5A1732019, S5A1732018, S5A17Y2035, S7B1892004, S5B1842043, D7B2152015, S5C1972054, 5DB2172003
Where was it sold?
US: PA, SC, IA, AL, MI, AR, SD, TX, ID, KY, NY, MN, MD, OH, WI, NV, CT, AZ, IL, OK, CA, FL, GA, OR, IN, NJ, CO, MT, KS, MO, WY, VA, VT, LA, NH, WV, TN, PR
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.
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