Hitachi Scenaria Computed Tomography System Hitachi Medical Systems… — Class II medical device recall Z-2392-2016
Terminated recall by Hitachi Medical Systems America Inc, reported 2016-08-17, distributed in CA, FL, GA, IA, IL, IN, MD, NC…. The firm discovered that the centrifugal force applied to the power supply may cause it to fail over time. The
| Recall number | Z-2392-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hitachi Medical Systems America Inc, Twinsburg, OH, United States |
| Recall initiated | 2015-06-30 |
| Classified | 2016-08-11 |
| Reported by FDA | 2016-08-17 |
| Terminated | 2016-11-01 |
| Distributed | CA, FL, GA, IA, IL, IN, MD, NC, NY, OH, PA, SD, TN, TX, WY |
| Countries outside the US | BR, MX |
| Quantity | 33 units |
| Serial numbers | S5002-S5014, S5017-S5038 |
Product
Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2392-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.