Z-1724-2020 Class II Ongoing
FDA device recall Z-1724-2020 was initiated by Canon Medical System, USA, INC. on March 25, 2019 and is designated Class II. 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.… The recall status is ongoing. Affected quantity: 10 devices.
Recall Details
- Product Type
- Devices
- Report Date
- April 22, 2020
- Initiation Date
- March 25, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 devices
Product Description
Canon Aquilion Prime SP, Model TSX-303B
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 Pattern
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.
Code Information
Canon Aquilion Prime SP, Multislice Helical CT Scanner, Model TSX-303B - Serial numbers 1LB1882092, 1LB1882088, 1LB18X2111, 1LB1882086, 1LB18X2129, 1LB18X2109, 1LB1882087, 1LB1882090, 1LB1892093, and 1OB1892102.