TOSHIBA SUPERCONDUCTING MRI SYSTEM Vantage Titan recallZ-2041-2024 · Canon Medical System, USA, INC. · initiated May 10, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Canon Medical System, USA, INC. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Device Design
What the company is doing
On 5/10/24, correction notices were sent to customers who were asked to do the following: 1) The replacement of the power cable securing parts that may cause smoke and fire, with parts made of materials with a higher degree of flame retardance, is now being released. 2) A firm representative will contact you to schedule a time to replace the power cable securing parts. 3) If any abnormalities such as unusual smells or smoke are observed before the work, immediately stop using the system and contact your service representative. 4) The parts required to address the defect are expected to be available no earlier than June 2024. 5) Complete and return the reply form via DocuSign or via email to [email protected] For questions, please contact our InTouch team at [email protected]
Recall details
- Recall number
- Z-2041-2024
- Status
- Open, Classified
- Initiated by the company
- May 10, 2024
- Posted by the FDA
- Jun 9, 2024
- Recalling firm
- Canon Medical System, USA, INC.
- Quantity
- 153
- Product code
- LNH
- FDA submissions
- K122613, K191128, K210164, K222968, K230355
- Distribution
- 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
Product description
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)
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
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
Devices named in this recall
5 devices in the FDA device registry whose identifier appears in the recall's code information.
- Vantage Galan 3T MRT-3020Canon Inc. · System, nuclear magnetic resonance imaging2 recalls3 reports
- TOSHIBA SUPERCONDUCTING MRI SYSTEM Vantage Elan MRT-2020Canon Inc. · System, nuclear magnetic resonance imaging2 recalls0 reports
- Vantage Titan 3T MRT-3010Canon Inc. · System, nuclear magnetic resonance imaging2 recalls0 reports
- TOSHIBA SUPERCONDUCTING MRI SYSTEM Vantage Titan MRT-1504Canon Inc. · System, nuclear magnetic resonance imaging2 recalls0 reports
- Vantage Orian MRT-1550Canon Inc. · System, nuclear magnetic resonance imaging2 recalls0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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