FDA Device recall Z-0974-2022
Artis Q floor, Model Number 10848280
- FDA Device
- Class II
- ongoing
- Published 2022-04-27
On 2022-04-27 the FDA classified a Class II recall of Artis Q floor, Model Number 10848280 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-0974-2022 |
| 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 Q floor, Model Number 10848280
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: 4056869009971; Serial Numbers: 103221 103217 103218 103345 103409 103340 103439 104007 103302 103232 104016 104005…UDI: 4056869009971; Serial Numbers: 103221 103217 103218 103345 103409 103340 103439 104007 103302 103232 104016 104005 103391 103404 104027 132002 103334 103354 103359 103030 103335 104012 103220 103013 103384 103035 104029 104020 103039 103050 103365 103279 104025 103285 103286 103207 103222 103230 103295 103310 103430 103432 104047 103001 103239 103353 104013 103444 132502 132500 103048 103315 103263 103356 132000 103028 103241 103293 103388 103389 132003 103245 103348 103253 Additional Serial Numbers as of 10/4/23: 160501 160519 160406 160900 160850 160959 160461 103053 103040 160903 126206 160905 160930 160967 160925 160469 |
|---|
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-0974-2022%22
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