Artis zee ceiling-interventional Fluoroscopic X-Ray System Model… — Class II medical device recall Z-1495-2021
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2021-05-05, distributed nationwide. Some Artis zee ceiling systems show an increased abrasion of the cabling at the cable outlet of the inner C-ar
| Recall number | Z-1495-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2021-03-26 |
| Classified | 2021-04-26 |
| Reported by FDA | 2021-05-05 |
| Distributed | Nationwide (US) |
| Quantity | 772 units |
| Serial numbers | 125000, 125001, 125002, 125003, 125004, 125005, 125006, 125008, 125009, 125010, 125011, 125013, 125015, 125016, 125017, 125019, 125021, 125022, 125023, 125024, 125100, 125105, 125106, 125108, 125109 and 475 more |
| Model numbers | 10094137 |
Product
Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137
Reason for recall
Some Artis zee ceiling systems show an increased abrasion of the cabling at the cable outlet of the inner C-arm, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system.
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-1495-2021. 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.