FDA Device recall Z-0603-2017
AXIOM Artis, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for single…
- FDA Device
- Class II
- terminated
- Published 2016-11-23
On 2016-11-23 the FDA classified a Class II recall of AXIOM Artis, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for single… by Siemens Medical Solutions Usa, citing the possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0603-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-01 |
| Published | 2016-11-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
AXIOM Artis, Angiographic x-ray system Product Usage: The Artis systems are 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. Procedures that can be performed with the Artis zee / zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee / zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.
Reason
The possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times.
Identifiers
| code_info | Model Numbers: 5917054, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717, 7728392 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0603-2017%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.