FDA Device recall Z-2392-2016
Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087
- FDA Device
- Class II
- terminated
- Published 2016-08-17
On 2016-08-17 the FDA classified a Class II recall of Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087 by Hitachi Medical Systems America, citing the firm discovered that the centrifugal force applied to the power supply may cause it to fail over time. The exam performed at the time of the failure will likely be lost, resul….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2392-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-30 |
| Published | 2016-08-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Hitachi Medical Systems America |
| Distribution | CA, FL, GA, IA, IL, IN, MD, NC, NY, OH, PA, SD, TN, TX, WY |
Product
Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087
Reason
The firm discovered that the centrifugal force applied to the power supply may cause it to fail over time. The exam performed at the time of the failure will likely be lost, resulting in the need to rescan the patient.
Identifiers
| code_info | Serial #'s: S5002-S5014; S5017-S5038 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2392-2016%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.