PlainRecalls
FDA Devices Moderate Class II Ongoing

Canon Aquilion Lightning, Model TSX-036A

Reported: April 22, 2020 Initiated: March 25, 2019 #Z-1719-2020

Product Description

Canon Aquilion Lightning, Model TSX-036A

Reason for Recall

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.

Details

Units Affected
6 devices
Distribution
Distribution was made to AK, AR, CA, FL, IA, ID, IL, KS, MA, MD, MI, MN, MO, MT, NC, ND, NH, NY, OH, OK, OR, PA, TN, TX, VT, WA, WI, and WV. There was government and military distribution but no foreign distribution.
Location
Tustin, CA

Frequently Asked Questions

What product was recalled?
Canon Aquilion Lightning, Model TSX-036A. Recalled by Canon Medical System, USA, INC.. Units affected: 6 devices.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 22, 2020. Severity: Moderate. Recall number: Z-1719-2020.