FDA Recall
Terminated
Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
Recall: Z-0142-2022
·
Initiated November 11, 2020
Recall
- Recall Number
- Z-0142-2022
- Event Number
- 88691
- Firm
- Canon Medical System, USA, INC.
- FEI Number
- 2020563
- Product Code
- KPS
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- November 11, 2020
- Terminated
- June 30, 2023
- Address
- 2441 Michelle Dr, Tustin, CA, 92780-7047
Description
Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
Reason
A software problem has been identified which could result in the diagnostic imaging system not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the diagnostic imaging system failing resulting in rescanning and reinjection of contrast medium.
Action
On November 11, 2020, Canon Medical Systems visited affected consignees and updated affected software. After completion of the software update, the consignee was provided a "Recall field Modification Instruction" document concerning the correction.
Distribution
US Nationwide distribution in the states of NV, AR MN.
Quantity
3 units