Company: Canon Medical System, USA, INC.
Date of Enforcement Report: 12/16/2020
Class II

PRODUCT

Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L – Product Usage: intended to acquire and display cross-sectional volumes of the whole body, including the head.

Recall Number: Z-0549-2021

REASON

A software problem has been identified which could result in the CT Scanner not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the CT scan failing resulting in rescanning and reinjection of contrast medium.

RECALLING FIRM/MANUFACTURER

Canon Medical System, USA, INC. on 11/9/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

60 units

DISTRIBUTION

U.S. Nationwide