FDA Device recall Z-0968-2022
Artis zee ceiling, Model Number 10094137
- FDA Device
- Class II
- ongoing
- Published 2022-04-27
On 2022-04-27 the FDA classified a Class II recall of Artis zee ceiling, Model Number 10094137 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-0968-2022 |
| 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 zee ceiling, Model Number 10094137
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: 4056869010052; Serial Numbers: 146669 146877 146996 146663 147100 146286 146292 146410 146676 148281 148299 147155…UDI: 4056869010052; Serial Numbers: 146669 146877 146996 146663 147100 146286 146292 146410 146676 148281 148299 147155 147678 146406 146407 146411 146166 147762 146121 147885 146710 125115 125276 125262 146945 125253 125213 125238 125245 147189 147190 146679 150011 146766 148429 125265 146232 147573 148454 147996 146408 146409 146728 148498 147889 146335 148404 146659 148499 148235 147909 147833 147847 147888 146898 148402 148333 150002 147273 125105 125106 147761 146814 146871 147783 147891 147581 147857 147882 146899 146368 146643 125100 147608 147983 146650 146361 146365 146366 146369 146912 146116 146164 146168 150017 147604 147079 125216 125202 125209 147371 146156 146343 148401 148486 148487 148488 148485 147899 147129 146260 146277 125013 147760 147923 147636 147081 146235 148423 146868 148422 148509 146758 146818 146741 146174 125255 147507 147047 147667 147679 148348 147685 125011 125111 147803 146173 146176 146186 146187 146189 146630 147630 146266 125249 125281 125286 12527 |
|---|
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-0968-2022%22
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