Siemens ARTIS pheno — Class II medical device recall Z-0807-2020
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2020-01-22, distributed nationwide. The potential exists for system movement to be permanently blocked by an activation of the collision sensor in
| Recall number | Z-0807-2020 |
|---|---|
| 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 | 2019-12-20 |
| Classified | 2020-01-13 |
| Reported by FDA | 2020-01-22 |
| Terminated | 2020-05-01 |
| Distributed | Nationwide (US) |
| Quantity | 6 |
| Serial numbers | 164231, 164234, 164240, 164241, 164242, 164244 |
| Model numbers | 10849000 |
Product
Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Reason for recall
The potential exists for system movement to be permanently blocked by an activation of the collision sensor integrated in the cover of the collimator even when no collision has occurred.
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-0807-2020. 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.