FDA Devices recall · Reported January 21, 2026
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
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 no…
Canon Medical System, USA, INC. recalled VANTAGE GALAN 3T Model MRT-3020/MEXL-3020 - a moderate-severity action.
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020 was recalled by Canon Medical System, USA, INC. in January 21, 2026. Reason: There is a potential for formation of ice occurring in the venting system of the superconducting magnet of th…. Check the official notice for the remedy. Verify recall #Z-1017-2026 with the FDA Devices before acting.
The recall
Canon Medical System, USA, INC. issued this moderate-severity FDA Devices recall-There is a potential for formation of ice occurring in the venting system of the superconducting magnet of th….
- Moderate
- severity level
- Class II
- classification
- January 21, 2026
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1017-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
Reason for recall
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. This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1017-2026 |
| Date reported | January 21, 2026 |
| Date initiated | December 19, 2025 |
| Recalling firm | Canon Medical System, USA, INC. |
| Firm location | Tustin, CA |
| Affected scope | 34 systems |
| Distribution | U.S. Nationwide distribution in the states of CA, CO, FL, IA, IL, IN, KS, MD, MO, MT, NV, NY, OH, OR, PA, PR, TX, VA, and WI. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1017-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026