ARTIS Q — Class II medical device recall Z-0459-2019
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2018-11-21, distributed nationwide. Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw connection to t
| Recall number | Z-0459-2019 |
|---|---|
| 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 | 2018-10-19 |
| Classified | 2018-11-13 |
| Reported by FDA | 2018-11-21 |
| Terminated | 2020-04-27 |
| Distributed | Nationwide (US) |
| Quantity | 15 |
| Serial numbers | 123055, 123056, 123200, 123201, 123202, 123205, 123206, 123207, 123208, 123209, 123211, 123212, 123216, 123219 |
Product
ARTIS Q.zen biplane with Material 10848355 - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee includes cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee can also support the acquisition of position triggered imaging for spatial data synthesis.
Reason for recall
Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw connection to the C-arm in the ceiling support
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-0459-2019. 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.