Artis Q/ Q zen systems — Class II medical device recall Z-1445-2015
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2015-04-22, distributed nationwide. potential issue with the Artis Q/ Q zen systems where it is possible that an electrical connection in the equi
| Recall number | Z-1445-2015 |
|---|---|
| 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 | 2015-03-19 |
| Classified | 2015-04-14 |
| Reported by FDA | 2015-04-22 |
| Terminated | 2015-08-06 |
| Distributed | Nationwide (US) |
| Quantity | 139 |
| Serial numbers | 103001, 103008, 103013, 103028, 103030, 105007, 105016, 105017, 109007, 109009, 109010, 109011, 109015, 109016, 109020, 109021, 109027, 109028, 109029, 109031, 109032, 109033, 109034, 109036, 109038 and 114 more |
| Model numbers | 10848281, 10848282, 10848283, 10848353, 10848354, 10848355 |
Product
Artis Q/ Q zen systems; Artis Q/ Q zen systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
Reason for recall
potential issue with the Artis Q/ Q zen systems where it is possible that an electrical connection in the equipment cabinet has not been installed correctly. The potentially defective connection in the equipment cabinet will be inspected and, if necessary, corrected.
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-1445-2015. 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.