AXIOM Artis angiographic x-ray system — Class II medical device recall Z-1150-2018
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2018-03-28, distributed in AZ, CA, FL, IA, IL, LA, MI, NC…. Certain systems may have leaking of the plastic coolant couplings, the liquid can enter into the flat panel de
| Recall number | Z-1150-2018 |
|---|---|
| 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 | 2018-01-05 |
| Classified | 2018-03-21 |
| Reported by FDA | 2018-03-28 |
| Terminated | 2018-08-23 |
| Distributed | AZ, CA, FL, IA, IL, LA, MI, NC, NJ, OH, OK, TX |
| Quantity | 22 |
| Reason classes | packaging |
| Serial numbers | 34999, 35004, 35018, 35045, 35046, 35048, 35050, 35054, 35057, 35059, 35061, 35064, 35071, 35073, 35075, 35083, 35095, 35097, 35098, 35108, 44011, 46004 |
| Model numbers | 7412807, 7413078, 7728392 |
Product
AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Reason for recall
Certain systems may have leaking of the plastic coolant couplings, the liquid can enter into the flat panel detector leading to a failure of the detector. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
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-1150-2018. 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.