Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004… recallZ-0284-2025 · Canon Medical System, USA, INC. · initiated Sep 17, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Canon Medical System, USA, INC. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-0284-2025
- Status
- Open, Classified
- Initiated by the company
- Sep 17, 2024
- Posted by the FDA
- Nov 1, 2024
- Recalling firm
- Canon Medical System, USA, INC.
- Quantity
- 27
- Product code
- KPS
- FDA submissions
- K231748
- Distribution
- US: NV, AR, MN, IA, IL, NC, LA, KS, MS, CA, AL, MD, CO, IN, TN, AZ, WI, VA
Product 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.
Code information (models, lots, serial numbers)
UDI-DI: 04987670103810, Software: V10.8 SP0013, V10.15 SP0006. Serial Numbers: 3DA1982001, 3DA2072002, 3DA2072003, 3DA20X2004, 3DA20Y2005, 3DA2112006, 3DA2132007, 3DA2162008, 3DA2192009, 3DA2242010, 3DA2252011, 3DA2262012, 3DA2272013, 3DA2272014, 3DA2282015, 3DA2292016, 3DA22Y2017, 3DA22Z2018, 3DA2322019, 3DA2322020, 3DA2332021, 3DA2332022, 3DA2342023, 3DA2352024, 3DA2352025, 3DB2362026, 3DB2422029
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- PET-CT SCANNER PCD-1000ACanon Inc. · System, X-Ray, Tomography, Computed1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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