Recall Z-2047-2021 ยท LNH System, Nuclear Magnetic Resonance Imaging
Canon Medical System, USA, INC.
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.
| Date | May 21, 2021 |
| Status | Open, Classified |
| Reason | The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire. |
| Root cause | Under Investigation by firm |
| Action | On May 25,2021, Canon issued a "URGENT: MEDICAL DEVICE CORRECTION" via USPS First Class Return Receipt. On June 24,2021, Canon sent an updated recall communication via USPS First Class Return Receipt to affected consignees to provide additional information. In addition to informing consignees about the recall, the firm asked consignees to take the following actions: 1. Your local Canon Service person will schedule time to replace the applicable part with a part that meets specifications. At the same time an inspection of the gantry will be performed. 2. Until such time that the modificati |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203553 | Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation, Feb 2, 2021 |