FDA Device recall Z-0970-2022
Artis zee biplane, Model Number 10094141
- FDA Device
- Class II
- ongoing
- Published 2022-04-27
On 2022-04-27 the FDA classified a Class II recall of Artis zee biplane, Model Number 10094141 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-0970-2022 |
| 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 biplane, Model Number 10094141
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: 4056869010069; Serial Numbers: 153131 153229 154827 155168 154408 153172 153315 153317 153992 154157 154616 155122…UDI: 4056869010069; Serial Numbers: 153131 153229 154827 155168 154408 153172 153315 153317 153992 154157 154616 155122 155149 153717 154551 153779 153280 153648 155265 153166 154536 154767 154454 155190 154715 153834 154789 154779 153169 154532 153803 131022 153110 131209 153199 154721 154722 153887 154571 154074 154012 155323 153191 153252 154612 153274 153239 153227 153889 154090 153285 153234 153236 154658 154847 154686 153273 153344 154095 153342 154567 154093 154502 153171 153197 153916 153831 131110 153883 153256 154704 153154 154086 153139 131707 153882 155189 153311 153211 154727 155151 153987 155266 155237 153740 131107 155105 153863 153772 154509 154079 153965 154462 153707 154480 155296 154794 154073 153263 153276 154076 153758 155148 131013 131219 153257 154792 155279 154156 156014 153112 153155 155193 153245 154799 153318 153720 153998 153271 153857 153226 153939 153951 154814 156011 153290 153678 153679 153277 154783 131221 153125 153128 153135 153743 153967 154731 15394 |
|---|
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-0970-2022%22
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