FDA Device recall Z-2041-2024
MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage Titan 3T MR…
- FDA Device
- Class II
- ongoing
- Published 2024-06-19
On 2024-06-19 the FDA classified a Class II recall of MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage Titan 3T MR… by Canon Medical System Usa, citing 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 le….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2041-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-10 |
| Published | 2024-06-19 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Canon Medical System Usa |
| Distribution | AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MT, NH, NJ, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, VT, WI, WV, WY |
Product
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)
Reason
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.
Identifiers
| code_info | Model/UDI-DI/Serial Numbers: MRT-1550 (MEXL-1550)/04987670103360/POA21X2002, S5A1982001, S5B22Z2041, S5B2172018, S2C22…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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FDA Device · Class II · 2026-02-04 · Canon Medical System Usa - Alphenix INFX-8000F, interventional fluoroscopic x-ray system
FDA Device · Class II · 2026-02-04 · Canon Medical System Usa
All Canon Medical System Usa recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2041-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.