FDA Device recall Z-0614-2018
Artis oneFloor-mounted system for uncompromised imaging
- FDA Device
- Class II
- terminated
- Published 2018-02-21
On 2018-02-21 the FDA classified a Class II recall of Artis oneFloor-mounted system for uncompromised imaging by Siemens Medical Solutions Usa, citing the possibility exists for the monitor display of Artis one systems with a DP Transceiver below revision 03 to experience blinking and/or a blue/black screen.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0614-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-22 |
| Published | 2018-02-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | AL, AR, CA, IN, LA, MI, MO, NC, NY, PA, TX, WA |
Product
Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. X-ray generator POLYDOROS A100 Plus
Reason
The possibility exists for the monitor display of Artis one systems with a DP Transceiver below revision 03 to experience blinking and/or a blue/black screen
Identifiers
| code_info | Serial # 82044; 82105; 82070; 82054; 82040;82038;82065 82108; 82010; 82039; 82109 82102 82066 |
|---|
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-0614-2018%22
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