FDA Device recall Z-0969-2022
Artis zee multi-purpose, Model Number 10094139
- FDA Device
- Class II
- ongoing
- Published 2022-04-27
On 2022-04-27 the FDA classified a Class II recall of Artis zee multi-purpose, Model Number 10094139 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-0969-2022 |
| 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 multi-purpose, Model Number 10094139
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: 4056869010076; Serial Numbers: 158469 157509 158449 158467 157660 157458 130110 158474 130028 130017 158170 158650…UDI: 4056869010076; Serial Numbers: 158469 157509 158449 158467 157660 157458 130110 158474 130028 130017 158170 158650 158652 158742 158624 158583 157698 130252 158530 157532 130241 157449 158413 157657 157136 130109 157988 157690 158091 158663 159034 158225 157560 130210 157436 157677 157528 159038 158422 157615 130240 157448 157165 158552 158556 158557 158561 158697 158701 159032 157977 157602 159046 157168 130212 130224 158605 158183 130253 158608 158438 130267 157642 157213 157164 158121 158619 157156 157559 157975 158670 157969 158254 158270 158272 158498 158134 158585 159054 157524 157588 158679 130102 158536 158749 158777 157750 157579 157573 157650 158216 158788 157554 157555 157671 158080 157521 158234 158566 158436 157928 158519 157696 158709 158257 158526 158569 157989 158495 159015 157488 158229 159058 158684 157999 159028 158744 130239 159037 158453 158206 158066 159026 158623 130708 157169 158220 158180 157508 157510 158032 130019 158226 157601 158244 158674 157658 15713 |
|---|
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-0969-2022%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.