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Recall Observatory FDA recall evidence

Device product

Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System, REF: MRT-1510 - 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.

Z-2045-2021

May 21, 2021

Class II

Product summary

Firm
Canon Medical System, USA, INC.
Event
Event 88014
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-2045-2021

Official wording

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

Code information: Affected Serial Numbers: S3C18Y2032, S3C1892029, S3C1912035, S3C2042045, S3A16Z2007, S3B1782012, S3A1692003, S3C1912036, S3C2012043, S3C1882028, S3C19Z2042, S3B17Y2016, S3C1842019, S3C1912034, S3C18Z2033, S3C2012044, S3C2082046, S3B1762010, S3B1762009, S3C1872025, S3C1932039, S3C1812017, S3C19Z2041, S3C1832018, S3B17X2015, S3A16Z2006, S3C1852021, S3C18X2030, S3C1932040, S3C1922038, S3A16Y2004, S3B1782013, S3C1842020, S3C1882026, S3C1912037, S3B1772011, S3A16Z2005, S3C1882027, S3B1782014

Distribution pattern: US Nationwide distributions in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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