FDA Device recall Z-1726-2020
Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1
- FDA Device
- Class II
- ongoing
- Published 2020-04-22
On 2020-04-22 the FDA classified a Class II recall of Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1 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-1726-2020 |
| 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 One, Model TSX-305A/3 V8.3 with FIRST 2.1
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 ONE GENESIS Edition, Whole-Body X-Ray CT Scanner, Model TSX-305A - Serial number 3LA1652001, 3LA17Y2020…Canon Aquilion ONE GENESIS Edition, Whole-Body X-Ray CT Scanner, Model TSX-305A - Serial number 3LA1652001, 3LA17Y2020, 3LB1872025, 3LA1762010, 3LA1772012, 3LA1762009, 3LB1882026, 3LA1752007, 3LA1762008, 3LA1772013, 3LA1732006, 3LA1772015, 3LA1772014, 3LA16Y2003, 3LA1792017, 3LA1782016, 3LA1712005, 3LB1832021, 3LA16Z2004, 3LA17Y2019, 3LB1842022, 3LA1772011, 3LB1852024, 3LA17X2018, 3OB1852023, 6LB18Y2013, 6LB1892008, 6LB1862002, 6LB1882007, 6LB1852001, 6LB1892009, 6LB18Y2011, 6LB1872005, 6LB1872006, and 6OB1862003. |
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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-1726-2020%22
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