ARTIS pheno systems with a Siemens Healthineers table or… — Class II medical device recall Z-1498-2023
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2023-05-10, distributed nationwide. If, during the procedure, X-ray has been released and a reference image has been stored, the following issue m
| Recall number | Z-1498-2023 |
|---|---|
| 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 | 2023-05-02 |
| Reported by FDA | 2023-05-10 |
| 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 |
| Model numbers | 10849000 |
Product
ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)- Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000
Reason for recall
If, during the procedure, X-ray has been released and a reference image has been stored, the following issue may occur: If "Adjust C-arm to Ref" is activated when the C-Arm is positioned outside of the working range the C-Arm will reach the target position with an inaccuracy of 5-10 mm. As a result, the message Endposition reached will be displayed .Leading to unintended direction of the movement causing crushing of a patient, staff member, operator, or equipmen Live images may not match the previously stored reference images. Overlay images may be shown inaccurate on anatomy (e.g., DSA Roadmap workflow does not match real anatomy). This may cause e.g., a vessel perforation in DSA roadmap.
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-1498-2023. 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.