FDA Device recall Z-0016-2016
Toshiba Aquilion CT System TSX-301C
- FDA Device
- Class II
- terminated
- Published 2015-10-21
On 2015-10-21 the FDA classified a Class II recall of Toshiba Aquilion CT System TSX-301C by Toshiba American Medical Systems, citing if two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0016-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-08 |
| Published | 2015-10-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Toshiba American Medical Systems |
| Distribution | PR |
Product
Toshiba Aquilion CT System TSX-301C
Reason
If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.
Identifiers
| code_info | system software V6.0 or later |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0016-2016%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.