ARTIS one with a hybrid cable- An angiography system developed for… — Class II medical device recall Z-1469-2023
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2023-05-03, distributed nationwide. Examination room monitor connected with the hybrid cable may have a display issue and no image function is ava
| Recall number | Z-1469-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2023-03-21 |
| Classified | 2023-04-27 |
| Reported by FDA | 2023-05-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BG, BR, CN, DE, ES, GB, ID, IN, IQ, JP, MA, MY, NG, NP, PL, RS, RU, SI, TH, TW, UA, VN, ZA |
| Quantity | 4 units |
| UPC / GTIN / UDI-DI | 04056869009964 |
| Serial numbers | 82225, 82237, 82326, 82327, 82349, 82403, 82407, 82432, 82433, 82438, 82447, 82454, 82467, 82477, 82482, 82484, 82494, 82495, 82498, 82500, 82502, 82506, 82508, 82512, 82515 and 120 more |
Product
ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures. Material Number: 10848600
Reason for recall
Examination room monitor connected with the hybrid cable may have a display issue and no image function is available
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-1469-2023. 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.