Recall Z-0142-2022 ยท KPS System, Tomography, Computed, Emission
Canon Medical System, USA, INC.
Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
| Date | Nov 11, 2020 |
| Status | Terminated |
| Reason | A software problem has been identified which could result in the diagnostic imaging system not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the diagnostic imaging system failing resulting in rescanning and reinjection of contrast medium. |
| Root cause | Software design |
| Action | On November 11, 2020, Canon Medical Systems visited affected consignees and updated affected software. After completion of the software update, the consignee was provided a "Recall field Modification Instruction" document concerning the correction. |
| Quantity | 3 units |
| Distribution | US Nationwide distribution in the states of NV, AR MN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203314 | Cartesion Prime (PCD-1000A/3) V10.8 Canon Medical Systems Corporation, Apr 23, 2021 |