The Recall Desk
HighFDA (Devices)·Z-2046-2021·Announced 2021-07-21

Canon MRI System Recalled for Flame-Retardancy Component Defect

Canon Medical System recalled its Vantage Titan 3T MRI systems due to a component lacking proper flame-retardancy standards. The defect could produce smoke or fire during use.

What this means for you

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 medical device with potential fire and smoke hazard from non-flame-retardant component. No illnesses, injuries, or deaths reported. Qualifies as 'risk-of-harm products where injury has not yet been reported' per the severity rubric.

Plain-English summary

Canon Medical System, USA, INC. is recalling Canon Vantage Titan 3T Premium Open-Bore MRI Systems (REF: MRT-3010) that were distributed nationwide. The systems contain a component that does not meet the appropriate flame-retardancy rating required for medical device safety.

The non-compliant component could result in smoke or fire during equipment operation. These systems are used in hospitals and medical facilities for diagnostic imaging to produce cross-sectional images of anatomical structures.

Owners and operators who received these systems should verify their serial numbers against FDA recall notice Z-2046-2021 and contact Canon Medical System for corrective action. Systems with affected serial numbers should not be used until the flame-retardancy issue is resolved.

The recalled product

Product
Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this syste
Manufacturer
Canon Medical System, USA, INC.
Category
Medical Device — Diagnostic Imaging
Hazard
  • fire
  • smoke
  • component-defect

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)

  • Affected Serial Numbers: A5B1182002
  • A5B11Y2005
  • A5D14X2032
  • A5A1082001
  • A5C12Y2017
  • A5D13Y2025
  • A5C1412028
  • S7A1642006
  • A5D13Y2026
  • A5F1562034
  • A5B1192004
  • A5C1222010
  • A5C1212009
  • A5C12X2016
  • A5G1692038
  • A5G1642036
  • A5C1232011
  • A5C1252012
  • A5D13Z2027
  • A5D1492030

Distribution

Distributed nationwide across the United States.

Related recalls

Same category