Recall Z-2047-2021— Canon Medical System, USA, INC.

Name: FDA recall Z-2047-2021
Creator: U.S. Food and Drug Administration
Published: 2021-05-21

Class II · Ongoing

Class II FDA medical device recall by Canon Medical System, USA, INC., initiated 2021-05-21. It names one FDA 510(k) clearance: K203553. Product: Canon Vantage Galan 3T, REF: MRT-3020 - 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 system is capable of non-contrast enhanced imaging, such as MRA.. Reason: The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire..

Recalling firm: Canon Medical System, USA, INC.
Classification: Class II
Status: Ongoing
Initiated: 2021-05-21
Firm location: Tustin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K203553 — Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation·cleared 2021-02-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Canon Vantage Galan 3T, REF: MRT-3020 - 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 system is capable of non-contrast enhanced imaging, such as MRA.

Reason for recall

The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.

Data sourced from openFDA. This site is unofficial and independent of the FDA.