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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Canon Medical System, USA, INC.: Canon MRI Systems Recalled Due to Potential Fire and Ignition Risk

Agency Publication Date: June 9, 2024
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Summary

Canon Medical System, USA, INC. has recalled 153 MRI systems across five different models, including Vantage Orian, Elan, Titan, and Galan systems. A terminal block used to secure the power supply cable for the MRI's gradient coil was not properly secured during manufacturing. This defect can cause the cable to disconnect, which may lead to electrical arcing, melting of the cable, and the potential for smoke or fire within the medical facility. Owners of these specific systems should contact the manufacturer immediately to ensure their equipment is inspected and corrected.

Risk

If the gradient coil power cable becomes loose or disconnected due to the faulty terminal block, electrical arcing can occur. This creates intense heat that can melt internal components, ignite materials, and cause a fire, posing a serious danger to patients and healthcare staff.

What You Should Do

  1. Check your MRI system to see if it is one of the affected models: Vantage Orian MRT-1550, Vantage Elan MRT-2020, Vantage Titan MRT-1504, Vantage Titan 3T MRT-3010, or Vantage Galan 3T MRT-3020.
  2. Locate the serial number on your device and cross-reference it with the affected units, such as Vantage Orian (Serial POA21X2002, S5A1982001, S5B22Z2041), Vantage Elan (Serial S1F18X2580, S1B1492068), or Vantage Galan 3T (Serial D5A2082005, D5A2092007).
  3. If your system is identified as affected, contact Canon Medical System, USA, INC. at 2441 Michelle Dr, Tustin, California, 92780 to schedule a technician visit or receive specific safety instructions.
  4. Follow any guidance provided by your healthcare facility's safety officer or the manufacturer regarding the continued use of the equipment until it has been inspected.
  5. For further information or questions regarding this recall, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer correction/inspection

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Vantage Orian MRT-1550 (MEXL-1550) MRI System
Model / REF:
MRT-1550
MEXL-1550
UPC Codes:
04987670103360
Lot Numbers (95):
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
Product: Vantage Elan MRT-2020 (MEXL-1520) MRI System
Model / REF:
MRT-2020
MEXL-1520
UPC Codes:
04987670101632
Lot Numbers:
S1F18X2580
S1B1492068
S1D17Y2461
S1F2052753
S1C1722390
S1C1682336
S1E1842517
S1E1842527
S1C1672334
Product: Vantage Titan MRT-1504 (MEXL-1504) MRI System
Model / REF:
MRT-1504
MEXL-1504
UPC Codes:
04987670102400
Lot Numbers:
U5B15Z2001
Product: Vantage Titan 3T MRT-3010 (MEXL-3010) MRI System
Model / REF:
MRT-3010
MEXL-3010
UPC Codes:
04987670101649
Lot Numbers:
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
Product: Vantage Galan 3T MRT-3020 (MEXL-3020) MRI System
Model / REF:
MRT-3020
MEXL-3020
UPC Codes:
04987670102615
Lot Numbers:
D5A2082005
D5A2092007
D5B2152013
S5B17X2034
D7B2182017
5DB2152002
S5B18X2046
S5A17X2033
D5A2062003
S5A1742021
D5B2212019
D5B2192016
S5A1662001
S5C18Y2048
S5A1732019
S5A1732018
S5A17Y2035
S7B1892004
S5B1842043
D7B2152015
S5C1972054
5DB2172003

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94609
Status: Active
Manufacturer: Canon Medical System, USA, INC.
Sold By: Canon Medical System, USA, INC.
Manufactured In: United States
Units Affected: 153
Distributed To: Pennsylvania, South Carolina, Iowa, Alabama, Michigan, Arkansas, South Dakota, Texas, Idaho, Kentucky, New York, Minnesota, Maryland, Ohio, Wisconsin, Nevada, Connecticut, Arizona, Illinois, Oklahoma, California, Florida, Georgia, Oregon, Indiana, New Jersey, Colorado, Montana, Kansas, Missouri, Wyoming, Virginia, Vermont, Louisiana, New Hampshire, West Virginia, Tennessee, Puerto Rico

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.