FDA Device recall Z-0549-2021
Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cross-sectional volume…
- FDA Device
- Class II
- terminated
- Published 2020-12-16
On 2020-12-16 the FDA classified a Class II recall of Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cross-sectional volume… by Canon Medical System Usa, citing A software problem has been identified which could result in the CT Scanner not proceeding to the next actual scan even though automatic start of the next scan is specified. This….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0549-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-09 |
| Published | 2020-12-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Canon Medical System Usa |
| Distribution | US |
Product
Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cross-sectional volumes of the whole body, including the head.
Reason
A software problem has been identified which could result in the CT Scanner not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the CT scan failing resulting in rescanning and reinjection of contrast medium.
Identifiers
| code_info | Serial Numbers: 8LA2052063, 8LA19Z2034 , 8LA19X2004, 8LA19Z2027, 8LA19Z2029, 8L…Serial Numbers: 8LA2052063, 8LA19Z2034 , 8LA19X2004, 8LA19Z2027, 8LA19Z2029, 8LA2052062, 8LA2042055, 8LA19Z2032, 8OA2052059, 8LA2042051, 8LA2032044, 8LA19X2002, 1LB1922175, 8LA2042050, 8LA19X2007, 8LA2012037, 8LA19Y2021, 8LA19Y2014, 8LA2042056, 8LA19Z2023, 8LA2052067, 8LA19Z2031, 8LA19Y2019, 8LA19Z2030, 8OA19Y2013, 8LA19Z2028, 8LA19Y2012, 8LA19Y2020, 8LA2032042, 8LA2052066, 8LA19X2003, 8LA19Y2022, 8LA19X2008, 8LA2042047, 8LA19Z2024, 8LA2032046, 8LA19Z2033, 8OA2042053, 8LA2012036, 8LA2042054, 8LA19Z2025, 8LA19Z2026, 8LA2022041, 8LA19X2010, 8LA2032043, 8OA19X2001, 8OA2052061, 8OA2042049, 8LA19Y2016, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0549-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.