Recall Z-0284-2025 ยท KPS System, Tomography, Computed, Emission
Canon Medical System, USA, INC.
Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
| Date | Nov 1, 2024 (initiated Sep 17, 2024) |
| Status | Open, Classified |
| Reason | When PET-CT system is executing reconstruction, if PET acquisition for another patient is performed (or PET reconstruction for another patient is performed from raw data processing), PET reconstruction control processing may hang up and PET reconstruction may stop as a result, which may necessitate repeat PET/CT examinations. |
| Root cause | Software design |
| Action | On 9/17/24, correction notices were emailed to customers asking them to do the following: 1) The modified software will be installed to all applicable systems to correct the occurrence of this problem, which should be available 09/2024. 2) To avoid the problem, until the corrective actions have been taken, it is strongly recommended that queue of more than one reconstruction be avoided. 3) If PET reconstruction stops unexpectedly, perform the following steps: <1> Execute "Reset PET System" and reboot the PET system. <2> Delete the remaining jobs in the reconstruction queue. <3> After the PET |
| Quantity | 27 |
| Distribution | US: NV, AR, MN, IA, IL, NC, LA, KS, MS, CA, AL, MD, CO, IN, TN, AZ, WI, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K231748 | Cartesion Prime (PCD-1000A/3) V10.15 Canon Medical Systems Corporation, Sep 12, 2023 |