Artis one fluoroscopic x-ray system and patient table Artis one is an… — Class II medical device recall Z-1148-2018
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2018-03-28, distributed in AL, AR, CA, FL, IN, LA, MI, MO…. Certain patient table systems may have a missing or incorrectly installed snap ring that could cause the bolt
| Recall number | Z-1148-2018 |
|---|---|
| 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 | 2018-01-12 |
| Classified | 2018-03-21 |
| Reported by FDA | 2018-03-28 |
| Terminated | 2018-08-28 |
| Distributed | AL, AR, CA, FL, IN, LA, MI, MO, NC, NY, PA, TX, WA |
| Quantity | 16 |
| Serial numbers | 82010, 82038, 82039, 82040, 82044, 82054, 82065, 82066, 82070, 82102, 82105, 82108, 82109, 82205, 82213, 82267 |
Product
Artis one fluoroscopic x-ray system and patient table Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Arts one include cardiac angiography, neuro-angiography, general angiography, rotational angiography; multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities.
Reason for recall
Certain patient table systems may have a missing or incorrectly installed snap ring that could cause the bolt to slide out of its base and the tabletop carriage to slide to the floor.
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-1148-2018. 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.