FDA Device recall Z-0303-2022
Artis Q.zen floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure M…
- FDA Device
- Class II
- terminated
- Published 2021-12-01
On 2021-12-01 the FDA classified a Class II recall of Artis Q.zen floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure M… by Siemens Medical Solutions Usa, citing if SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, ma….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0303-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-10-20 |
| Published | 2021-12-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Artis Q.zen floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848353
Reason
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
Identifiers
| code_info | Serial Numbers: 105500 105503 105501 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0303-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.