FDA Device recall Z-2686-2017
Artis zee,x-ray system, angiographic Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic ima…
- FDA Device
- Class II
- terminated
- Published 2017-07-26
On 2017-07-26 the FDA classified a Class II recall of Artis zee,x-ray system, angiographic Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic ima… by Siemens Medical Solutions Usa, citing failures can result due to a component defect on Artis zee systems with an A100 Plus generator of a certain delivery lot and 2-focus Megalix Cat Plus tube unit.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2686-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-02-03 |
| Published | 2017-07-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | AR, IA, IL, KS, MI, MN, NY, OH, WI, WV |
Product
Artis zee,x-ray system, angiographic Artis zee 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. Procedures that can be performed with the Artis zee include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee systems can also support the acquisition of position triggered imaging for spatial data synthesis
Reason
Failures can result due to a component defect on Artis zee systems with an A100 Plus generator of a certain delivery lot and 2-focus Megalix Cat Plus tube unit.
Identifiers
| code_info | Serial Numbers: 124081 124061 137662 137668 137391 148001 147871 154827 154847 153197 131101 154035 |
|---|
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-2686-2017%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.