ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/… — Class II medical device recall Z-1311-2023
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2023-04-05, distributed nationwide. In the event of any unintended table movement, the system may not detect the incorrect direction, could lead t
| Recall number | Z-1311-2023 |
|---|---|
| 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 | 2023-02-02 |
| Classified | 2023-03-30 |
| Reported by FDA | 2023-04-05 |
| Distributed | Nationwide (US) |
| Quantity | 141 units |
| UPC / GTIN / UDI-DI | 04056869046877 |
| Serial numbers | 164011, 164013, 164018, 164019, 164021, 164022, 164024, 164025, 164026, 164027, 164028, 164033, 164034, 164048, 164049, 164053, 164054, 164055, 164057, 164060, 164061, 164063, 164064, 164066, 164068 and 116 more |
Product
ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.
Reason for recall
In the event of any unintended table movement, the system may not detect the incorrect direction, could lead to the injury of a patient, staff member, operator, or equipment.
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-1311-2023. 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.