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.
Recall
- Recall Number
- Z-0284-2025
- Event Number
- 95471
- Firm
- Canon Medical System, USA, INC.
- FEI Number
- 2020563
- Product Code
- KPS
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- September 17, 2024
- Posted
- November 1, 2024
- Address
- 2441 Michelle Dr, Tustin, CA, 92780-7047
Description
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.
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.
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 system has rebooted, start up raw data processing and select the appropriate data. <4> Perform one of the following from the pull-down menu for "Helical for AC". . Specify the helical scan line number to perform CT reconstruction. . Specify "Select Image" and select the CT data used for attenuation correction. <5> Perform PET reconstruction. If PET reconstruction cannot be performed because the CT data for attenuation correction is not saved or for any other reason, follow the procedure below. Specifying helical scan data used for attenuation correction. For helical + PET acquisition, the helical scan data used for attenuation correction can be specified. When "Original" is specified, the CT data used for reconstruction synchronized with scanning is used. When the helical scan line number is specified, reconstruction for helical scan is performed first. When "Select Image" is specified, the data used for attenuation correction can be selected from the displayed list, see Image Reconstruction in the operation manual. 4) Share this information with all users, radiologists, clinical engineering, or biomedical groups. 5) Complete and return the response form via email to [email protected] 6) If you have questions please email them to the address above.
US: NV, AR, MN, IA, IL, NC, LA, KS, MS, CA, AL, MD, CO, IN, TN, AZ, WI, VA
27