Siemens Artis one systems with a Display Port… — Class II medical device recall Z-0298-2021
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2020-11-04, distributed nationwide. Potential malfunction in which the examination room monitor may become intermittently dysfunctional (e.g., no
| Recall number | Z-0298-2021 |
|---|---|
| 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 | 2020-09-21 |
| Classified | 2020-10-27 |
| Reported by FDA | 2020-11-04 |
| Terminated | 2021-08-03 |
| Distributed | Nationwide (US) |
| Quantity | 22 units |
| Reason classes | device malfunction |
| Serial numbers | 82010, 82038, 82039, 82040, 82044, 82054, 82065, 82066, 82070, 82102, 82105, 82108, 82109, 82205, 82213, 82217, 82267, 82308, 82354, 82355, 82378, 82383 |
| Model numbers | 10848600 |
Product
Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System Model: 10848600 - Product Usage: he examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. The Artis one can also support the acquisition of position triggered imaging for spatial data synthesis.
Reason for recall
Potential malfunction in which the examination room monitor may become intermittently dysfunctional (e.g., no display/flicking/wrong resolution).
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-0298-2021. 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.