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

FDA device recall Z-0284-2025 · posted 2024-11-01 · Open, Classified

Recall details

Recalling firm

Canon Medical System, USA, INC.

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.

Action taken

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 RAffairs@us.medical.canon 6) If you have questions please email them to the address above.

Root cause

Software design

Status

Open, Classified

Product code

KPS

Quantity affected

27

Distribution

US: NV, AR, MN, IA, IL, NC, LA, KS, MS, CA, AL, MD, CO, IN, TN, AZ, WI, VA

Date initiated

2024-09-17

Date posted

2024-11-01

Location

Tustin, CA

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