Recall Z-1726-2020 ยท JAK System, X-Ray, Tomography, Computed
Canon Medical System, USA, INC.
Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1
| Date | Apr 10, 2020 (initiated Mar 25, 2019) |
| Status | Open, Classified |
| Reason | Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur. |
| Root cause | Software design |
| Action | Recall letters dated 3/25/2019 were issued on 3/25/2019 via USPS return receipt mail. |
| Quantity | 35 devices |
| Distribution | Distribution was made to AK, AR, CA, FL, IA, ID, IL, KS, MA, MD, MI, MN, MO, MT, NC, ND, NH, NY, OH, OK, OR, PA, TN, TX, VT, WA, WI, and WV. There was government and military distribution but no foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170177 | Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 Toshibamedical Systems Corporation, Jun 30, 2017 |