Company: Canon Medical System, USA, INC.
Date of Enforcement Report: 4/22/2020
Class II
PRODUCT
Canon Aquilion Lightning, Model TSX-036A
Recall Number: Z-1719-2020
REASON
Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.
RECALLING FIRM/MANUFACTURER
Canon Medical System, USA, INC. on 3/25/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
6 devices
DISTRIBUTION
US Nationwide