MRI Systems Power Cable Terminal Block Fire Hazard Recall
Canon Medical MRI systems are being recalled because the terminal block securing the power cable may disconnect, potentially causing electrical arcing and fire. 153 units are affected across the United States and Puerto Rico.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves an FDA Class II medical device with a potential fire hazard due to an unsecured cable terminal block. No injuries or property damage have been reported. Per the severity rubric, this constitutes a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Canon Medical System, USA, Inc. is recalling five models of Vantage MRI systems: Vantage Orian MRT-1550, Vantage Elan MRT-2020, Vantage Titan MRT-1504, Vantage Titan 3T MRT-3010, and Vantage Galan 3T MRT-3020. A total of 153 units have been distributed.
The terminal block that secures the power supply cable for the gradient coil was not secured as designed. This defect could allow the cable to disconnect during operation, potentially causing electrical arcing. The arcing could lead to melting of the cable, followed by ignition, smoke, and fire.
The affected units have been distributed throughout the United States and Puerto Rico to healthcare facilities.
Healthcare facilities should contact Canon Medical System, USA, Inc. for instructions regarding remediation of affected systems.
The recalled product
- 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)
- Manufacturer
- Canon Medical System, USA, INC.
- Category
- Medical Device — MRI System
- Affected units
- 153
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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