FDA Device recall Z-1719-2020
Canon Aquilion Lightning, Model TSX-036A
- FDA Device
- Class II
- ongoing
- Published 2020-04-22
On 2020-04-22 the FDA classified a Class II recall of Canon Aquilion Lightning, Model TSX-036A 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-1719-2020 |
| 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 Lightning, Model TSX-036A
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 Lightning, TSX-036A - Serial numbers 4LC1892122, 4LC1892125, 4LC1892129, 4LC1882114, 4OC1912163, and 4OC18Y2149. |
|---|
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-1719-2020%22
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