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