ARTIS Pheno — Class II medical device recall Z-2524-2018
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2018-08-01, distributed in AL, CA, CO, FL, IL, KY, MA, ME…. During manual LAO/RAO rotation at maximum speed or a combination of LAO/RAO and Cran/Caud rotation at maximum
| Recall number | Z-2524-2018 |
|---|---|
| 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 | 2018-05-30 |
| Classified | 2018-07-20 |
| Reported by FDA | 2018-08-01 |
| Terminated | 2020-02-14 |
| Distributed | AL, CA, CO, FL, IL, KY, MA, ME, MI, MN, MS, NJ, NY, OH, TN, TX, UT, VA |
| Quantity | 40 in |
| Model numbers | 10849000 |
Product
ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000
Reason for recall
During manual LAO/RAO rotation at maximum speed or a combination of LAO/RAO and Cran/Caud rotation at maximum speed, the possibility exists for the safety monitoring within the system control to become activated. As a result, the C-arm stops the rotation and can drop up to 40 mm (1.6 ).
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-2524-2018. 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.