FDA Device recall Z-0967-2022
Artis zee floor, Model Number 10094135
- FDA Device
- Class II
- ongoing
- Published 2022-04-27
On 2022-04-27 the FDA classified a Class II recall of Artis zee floor, Model Number 10094135 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-0967-2022 |
| 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 floor, Model Number 10094135
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: 4056869010045; Serial Numbers: 138481 137729 124071 138390 135944 137623 135111 135112 124267 124253 137165 124335…UDI: 4056869010045; Serial Numbers: 138481 137729 124071 138390 135944 137623 135111 135112 124267 124253 137165 124335 124338 124400 137391 137714 124081 135120 137282 135358 137618 137226 135757 136513 137103 137118 137461 135102 136042 138124 138132 135927 137510 138260 138012 138058 137193 135986 135935 135953 138055 124303 135841 138497 135200 135201 135279 124061 135879 135229 136113 135990 138035 138214 137479 138156 124083 137532 137540 136077 124102 137314 135862 124116 135235 135117 135920 137295 136168 138087 137582 137592 138221 138112 135366 138084 137075 124115 135843 138057 138118 138061 135779 136224 124395 137130 137188 137131 137146 137662 135137 138071 138102 138486 136579 137388 137470 124007 137011 136280 138311 136286 137347 135109 137766 124384 138128 137638 137731 124383 138017 124394 137595 135144 135145 136362 138259 137245 137620 137335 137607 137617 136318 136234 138402 135151 135421 135760 136500 135217 137369 136031 136032 137421 135124 136084 137569 13602 |
|---|
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-0967-2022%22
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