Device product
Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
Z-0142-2022
Product summary
- Event
- Event 88691
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-0142-2022
Official wording
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.
Code information: Affected serial numbers: 3DA1982001, 3DA2072002, 3DA2072003
Distribution pattern: US Nationwide distribution in the states of NV, AR MN.
Derived failure modes
-
Device software or design
software problem