FDA Device recall Z-1903-2019
Siemens Artis Q.zen ceiling-Interventional Fluoroscopic X-Ray System Model Number: 10848354
- FDA Device
- Class II
- terminated
- Published 2019-07-10
On 2019-07-10 the FDA classified a Class II recall of Siemens Artis Q.zen ceiling-Interventional Fluoroscopic X-Ray System Model Number: 10848354 by Siemens Medical Solutions Usa, citing artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1903-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-06 |
| Published | 2019-07-10 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Siemens Artis Q.zen ceiling-Interventional Fluoroscopic X-Ray System Model Number: 10848354
Reason
Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel
Identifiers
| code_info | Serial Numbers: 111005 111000 111002 111125 111123 111109 111128 111124 111122 111104 111106 111121 111127 111137 111135 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1903-2019%22
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