Z-0142-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 27, 2021
- Initiation Date
- November 11, 2020
- Termination Date
- June 30, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product Description
Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of NV, AR MN.
Code Information
Affected serial numbers: 3DA1982001, 3DA2072002, 3DA2072003