Canon Aquilion Prime SP, Model TSX-303B
- Company
- Canon Medical System, Usa, Inc.
- Recall Initiated
- March 25, 2019
- Posted
- April 10, 2020
- Recall Number
- Z-1724-2020
- Quantity
- 10 devices
- Firm Location
- Tustin, CA
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.
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.
Lot / Code Info
Canon Aquilion Prime SP, Multislice Helical CT Scanner, Model TSX-303B - Serial numbers 1LB1882092, 1LB1882088, 1LB18X2111, 1LB1882086, 1LB18X2129, 1LB18X2109, 1LB1882087, 1LB1882090, 1LB1892093, and 1OB1892102.
Root Cause
Software design
Action Taken
Recall letters dated 3/25/2019 were issued on 3/25/2019 via USPS return receipt mail.