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U.S. Department of Health and Human Services

Class 2 Device Recall Diagnostic imaging system

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 Class 2 Device Recall Diagnostic imaging systemsee related information
Date Initiated by FirmSeptember 17, 2024
Date PostedNovember 01, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0284-2025
Recall Event ID 95471
510(K)NumberK231748 
Product Classification System, tomography, computed, emission - Product Code KPS
ProductCartesion 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 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
Recalling Firm/
Manufacturer		 Canon Medical System, USA, INC.
2441 Michelle Dr
Tustin CA 92780-7047
For Additional Information Contact
714-730-5000
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionOn 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 RAffairs@us.medical.canon 6) If you have questions please email them to the address above.
Quantity in Commerce27
DistributionUS: NV, AR, MN, IA, IL, NC, LA, KS, MS, CA, AL, MD, CO, IN, TN, AZ, WI, VA
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KPS
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