Z-2047-2021 Class II Ongoing
FDA device recall Z-2047-2021 was initiated by Canon Medical System, USA, INC. on May 21, 2021 and is designated Class II. 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. The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- July 21, 2021
- Initiation Date
- May 21, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
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.
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.
Code Information
Affected Serial Numbers: D5A2082005, S7B1992017, S5C1912050, S5A1662001, D5A2092007, S5B17X2034, S5B18X2046, S5A17X2033, S5A1742021, D5A2062003, S5C18Y2048, S5A1732019, S5A1732018, S5A17Y2035, S7B1892004, S5B1842043, S7B1962013, S5C1972054