ARTIS Pheno Interventional Fluoroscopic X-Ray System — Class II medical device recall Z-3190-2018
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2018-09-26, distributed nationwide. Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configur
| Recall number | Z-3190-2018 |
|---|---|
| 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 | 2018-07-29 |
| Classified | 2018-09-18 |
| Reported by FDA | 2018-09-26 |
| Terminated | 2019-05-17 |
| Distributed | Nationwide (US) |
| Quantity | 429 total |
| Reason classes | temperature control |
| Model numbers | 10849000 |
Product
ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000
Reason for recall
Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. This unintentional system behavior may occur while the unit is powered down for long periods (e.g. at night).
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-3190-2018. 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.