MRI System Spatial Field Gradient Values Incorrectly Displayed and Documented
Vantage Titan MRI systems display and document spatial field gradient values that are lower than correct, which may cause discomfort in patients with MR-conditional devices.
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: Class II device involving risk to patients with MR-conditional implanted devices due to incorrect display and documentation of safety-critical spatial field gradient values. Per rubric, risk-of-harm products without reported injury are capped at score 3.
Plain-English summary
Canon Medical System, USA, INC. is recalling certain Vantage Titan MRI systems (Model MRT-1504) distributed nationwide in the United States and U.S. territories. The recall affects 40 units identified by specific serial numbers available in the full recall details.
For some affected systems, the maximum spatial field gradient (SFG) values displayed in the operation window and described in the safety manual are lower than the correct values. These values are important parameters for MRI system operation and safety assessment.
Patients with MR-conditional devices may experience discomfort during MRI scans performed on affected systems. The incorrect SFG values could impact the safety assessment for patients with implanted medical devices. No illnesses or injuries have been reported.
Healthcare providers with affected systems should contact Canon Medical System, USA, INC. for corrected SFG values and updated safety documentation.
The recalled product
- Product
- Vantage Titan, Model: MRT-1504
- Manufacturer
- Canon Medical System, USA, INC.
- Category
- Medical Device — MRI System
- Affected units
- 40
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)
- UDI-DI: 04987670102400. Serial Numbers: U4B15Y2102
- U5B15Z2001
- U4B1492080
- U4B1582100
- U4B1582099
- U4B1522091
- U4B1512089
- U4B1432067
- U4B1522093
- U4B1452073
- U4B1442069
- U4B1442068
- U4B1642106
- U4B1432066
- U4B15X2101
- U4B14Y2083
- U4B1452071
- U4B1512087
- U4B1652107
- U4B1552097
Distribution
Part of a larger recall action
This product is one of 3 recalled by Canon Medical System, USA, INC. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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