AXIOM Artis BA — Class II medical device recall Z-2016-2019
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2019-07-31, distributed nationwide. A tolerance issue in the power supply of the generator control above a specific value may cause generator A100
| Recall number | Z-2016-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2019-06-12 |
| Classified | 2019-07-22 |
| Reported by FDA | 2019-07-31 |
| Terminated | 2020-09-18 |
| Distributed | Nationwide (US) |
| Quantity | 7 |
| Serial numbers | 28139, 28144, 28154, 28155, 28156, 28159, 28160 |
| Model numbers | 5904656 |
Product
AXIOM Artis BA, Model Number 5904656
Reason for recall
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
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-2016-2019. 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.