ARTIS Pheno Interventional Fluoroscopic X-Ray System — Class II medical device recall Z-2283-2018
Completed recall by Siemens Medical Solutions USA, Inc, reported 2018-07-04, distributed in AL, CA, CO, FL, IL, KY, MA, MI…. If the C-arm is manually moved in the longitudinal direction to a fully extended position, the system's safety
| Recall number | Z-2283-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2018-05-01 |
| Classified | 2018-06-22 |
| Reported by FDA | 2018-07-04 |
| Terminated | 2020-03-18 |
| Distributed | AL, CA, CO, FL, IL, KY, MA, MI, MN, MS, NE, NJ, NY, OH, TN, TX, UT, VA |
| Countries outside the US | AE, AT, AU, BE, CH, DE, DK, ES, FR, GB, IT, JP, KW, NL, NO, SE, TH, TR, TW, ZA |
| Quantity | 39 |
| Model numbers | 10849000 |
Product
ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000
Reason for recall
If the C-arm is manually moved in the longitudinal direction to a fully extended position, the system's safety stop mechanism may be activated. As a result, the C-arm stops the movement and can drop up to 20 mm (0.8 ). Under certain circumstances, the cover of the detector or collimator can touch and possibly injure the patient due to the C-arm drop. This could lead to a situation in which it is necessary to stop the clinical treatment or continue the 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-2283-2018. 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.