MRI systems recalled over ice that may block magnet venting
Canon Medical Systems is recalling 22 Vantage Titan 3T MRI systems because ice in the magnet venting system could lead to a helium vessel rupture during a quench.
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: Scored 3 under the risk-of-harm criterion: the firm describes a possible helium vessel rupture releasing gas into the scanning room, and no injuries are reported.
Plain-English summary
The Vantage Titan 3T MRI system, model MRT-3010/MEXL-3010, is being recalled by Canon Medical System, USA, INC.
The record states there is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. If a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths and the pressure in the helium vessel may rise. The firm states this pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room.
The record lists 22 systems under UDI-DI 04987670101649, with model and serial numbers recorded in the enforcement record. Distribution was nationwide in the United States, across California, Colorado, Florida, Iowa, Illinois, Indiana, Kansas, Maryland, Missouri, Montana, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Texas, Virginia and Wisconsin. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Facilities should follow Canon's instructions.
The recalled product
- Product
- VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
- Manufacturer
- Canon Medical System, USA, INC.
- Category
- Medical Device — MRI
- Affected units
- 22
Distribution
Part of a larger recall action
This product is one of 2 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.
See all 2 products in this recall →Related recalls
Same manufacturer · Canon Medical System, USA, INC.
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