Canon Aquilion One — Class II medical device recall Z-1726-2020
Ongoing recall by Canon Medical System, USA, INC., reported 2020-04-22, distributed in AK, AR, CA, FL, IA, ID, IL, KS…. Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be s
| Recall number | Z-1726-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Canon Medical System, USA, INC., Tustin, CA, United States |
| Recall initiated | 2019-03-25 |
| Classified | 2020-04-16 |
| Reported by FDA | 2020-04-22 |
| Distributed | 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 |
| Quantity | 35 devices |
| Serial numbers | 3LA1652001, 3LA16Y2003, 3LA16Z2004, 3LA1712005, 3LA1732006, 3LA1752007, 3LA1762008, 3LA1762009, 3LA1762010, 3LA1772011, 3LA1772012, 3LA1772013, 3LA1772014, 3LA1772015, 3LA1782016, 3LA1792017, 3LA17X2018, 3LA17Y2019, 3LA17Y2020, 3LB1832021, 3LB1842022, 3LB1852024, 3LB1872025, 3LB1882026, 3OB1852023 and 10 more |
| Model numbers | TSX-305A, TSX-305A/3, V8.3 |
Product
Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1726-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.