FDA Device recall Z-0271-2020
Hitachi Scenaria Whole-body X-ray CT System
- FDA Device
- Class II
- terminated
- Published 2019-11-13
On 2019-11-13 the FDA classified a Class II recall of Hitachi Scenaria Whole-body X-ray CT System by Hitachi Medical Systems America, citing there is a possibility that the cables to the controller unit may not be affixed properly, creating the potential for a cable to detach during scanning and eject from the system.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0271-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-16 |
| Published | 2019-11-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Hitachi Medical Systems America |
| Distribution | CA, FL, GA, IA, IN, MD, MT, NC, NY, OH, OK, PR, SD, TN, TX, WY |
Product
Hitachi Scenaria Whole-body X-ray CT System
Reason
There is a possibility that the cables to the controller unit may not be affixed properly, creating the potential for a cable to detach during scanning and eject from the system.
Identifiers
| code_info | Scenaria units S5002-S5014, S5017-S5044 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0271-2020%22
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