FDA Device recall Z-1598-2024
Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 10094137 Artis zee mul…
- FDA Device
- Class II
- ongoing
- Published 2024-04-24
On 2024-04-24 the FDA classified a Class II recall of Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 10094137 Artis zee mul… by Siemens Medical Solutions Usa, citing coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will displ….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1598-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-21 |
| Published | 2024-04-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 10094137 Artis zee multi-purpose- 10094139 Artis zee biplane- 10094141 Artis zeego- 10280959 Artis Q floor- 10848280 Artis Q ceiling- 10848281 Artis Q biplane- 10848282 Artis Q zeego- 10848283 Artis Q.zen floor- 10848353 Artis Q.zen ceiling- 10848354 Artis Q.zen biplane- 10848355 Artis zee floor MN- 10094142 Artis zee biplane MN- 10094143
Reason
Coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message TUBE HOT, have a break . the system cannot be operated normally, may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system
Identifiers
| code_info | Model/UDI-DI: Artis zee floor- 4056869010045 Artis zee ceiling- 4056869010052 Artis zee multi-purpose- 4056869010076 Ar…Model/UDI-DI: Artis zee floor- 4056869010045 Artis zee ceiling- 4056869010052 Artis zee multi-purpose- 4056869010076 Artis zee biplane- 4056869010069 Artis zee floor MN- 4056869010090 Artis zee biplane MN- 4056869010106 Artis zeego- 4056869010083 Artis Q floor- 4056869009971 Artis Q ceiling- 4056869009988 Artis Q biplane- 4056869009995 Artis Q zeego- 4056869010007 Artis Q.zen floor- 4056869010014 Artis Q.zen ceiling- 4056869010021 Artis Q.zen biplane- 4056869010038 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1598-2024%22
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