FDA Device recall Z-1724-2020
Canon Aquilion Prime SP, Model TSX-303B
- FDA Device
- Class II
- ongoing
- Published 2020-04-22
On 2020-04-22 the FDA classified a Class II recall of Canon Aquilion Prime SP, Model TSX-303B by Canon Medical System Usa, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1724-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-03-25 |
| Published | 2020-04-22 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Canon Medical System Usa |
| Distribution | 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, WV |
Product
Canon Aquilion Prime SP, Model TSX-303B
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.
Identifiers
| code_info | Canon Aquilion Prime SP, Multislice Helical CT Scanner, Model TSX-303B - Serial numbers 1LB1882092, 1LB1882088, 1LB18X2…Canon Aquilion Prime SP, Multislice Helical CT Scanner, Model TSX-303B - Serial numbers 1LB1882092, 1LB1882088, 1LB18X2111, 1LB1882086, 1LB18X2129, 1LB18X2109, 1LB1882087, 1LB1882090, 1LB1892093, and 1OB1892102. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1724-2020%22
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