FDA Device recall Z-0973-2022
Artis zeego, Model Number 10280959
- FDA Device
- Class II
- ongoing
- Published 2022-04-27
On 2022-04-27 the FDA classified a Class II recall of Artis zeego, Model Number 10280959 by Siemens Medical Solutions Usa, citing if the 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 wil….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0973-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-02-23 |
| Published | 2022-04-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Artis zeego, Model Number 10280959
Reason
If the 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". Several minutes later the system will block X-ray to prevent further damage and display the message "NO XRAY: TUBE TOO HOT".
Identifiers
| code_info | UDI: 4056869010083; Serial Numbers: 160851 160879 161046 160395 160484 161041 160351 161218 160999 161032 161204 161226…UDI: 4056869010083; Serial Numbers: 160851 160879 161046 160395 160484 161041 160351 161218 160999 161032 161204 161226 160838 160449 160852 160463 160411 160106 160134 160136 160953 160347 160913 161206 160961 160312 160877 161008 160488 160997 160864 160448 160937 160965 160427 160455 160884 160486 161236 160435 160451 160823 160951 160384 160431 160100 160916 160814 160872 160391 160470 160321 160376 160915 160447 161021 160481 160401 160119 160403 160404 160871 160989 161051 160874 161223 161007 160862 160438 160860 160378 160419 160889 160450 160854 160429 160149 160878 160137 160152 160153 160154 160138 160446 160368 160957 160992 160394 160856 160432 160147 160433 160483 160402 161005 161209 160813 160998 160356 160425 160148 160337 160460 160485 160443 160370 160912 160381 160412 161215 160919 161217 160407 160876 160861 160325 160885 160910 161000 160494 160390 161050 160507 160144 160833 160001 160363 160825 160341 160139 160942 160816 160430 160873 161233 161234 160840 16000 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0973-2022%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.