Z-0284-2025Class II

Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that...

Name: Z-0284-2025 Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that...
Creator: Canon Medical System, USA, INC.
Published: 2024-09-17
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2024-09-17 / Open, Classified / root cause: software

FDA source

Canon Medical System, USA, INC. began a recall of 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... on 2024-09-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0284-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-17
Posted: 2024-11-01
Recalling firm: Canon Medical Systems USA, Inc.
Product: 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.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: 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 tag: software
FDA 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 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.
Quantity in commerce: 27
Distribution: US: NV, AR, MN, IA, IL, NC, LA, KS, MS, CA, AL, MD, CO, IN, TN, AZ, WI, VA
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0284-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0284-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-13	2024-11-01

Product code KPS

K231748Class IICartesion Prime (PCD-1000A/3) V10.15Canon Medical Systems Corporation / cleared 2023-09-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)