Company: Canon Medical System, USA, INC.
Date of Enforcement Report: 10/27/2021
Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
Recall Number: Z-0142-2022
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.
Canon Medical System, USA, INC. on 11/11/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE