Drug recall
Canon Aquilion Lightning, Model TSX-036A
FDA recall event 84954 · Class II · Canon Medical System, USA, INC.
Key facts
| Event ID | 84954 |
|---|---|
| Recall numbers | Z-1719-2020, Z-1720-2020, Z-1721-2020, Z-1722-2020, Z-1723-2020, Z-1724-2020, Z-1725-2020, Z-1726-2020 |
| Recalling firm | Canon Medical System, USA, INC. |
| Product type | Devices |
| Products | Canon Aquilion Lightning, Model TSX-036A, Canon Aquilion One, Model TSX-301A, Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1, Canon Aquilion One Vision, Model TSX-301C, Canon Aquilion Precision, Model TSX-304A and 3 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Mar 25, 2019 |
| Report date | Apr 22, 2020 |
| City | Tustin |
| State | CA |
| Country | United States |
| FEI number | 2020563 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: