FDA Device recall Z-1721-2020
Canon Aquilion Premium, Model TSX-301B
- FDA Device
- Class II
- ongoing
- Published 2020-04-22
On 2020-04-22 the FDA classified a Class II recall of Canon Aquilion Premium, Model TSX-301B 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-1721-2020 |
| 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 Premium, Model TSX-301B
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 Whole-Body X-Ray CT Scanner, 160-detector row CT, Model TSX-301B - Serial numbers 7CA18Y2002 and 7CA1892001. |
|---|
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-1721-2020%22
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