Artis zee biplane, Model Number 10094141
Check against the official notice below — it lists the full affected range.
Siemens Medical Solutions USA, Inc. is recalling 373 Artis zee biplane X-ray systems (Model Number 10094141) distributed nationwide. The systems have a defect in their cooling circuit that may allow coolant levels to drop below safe operating levels. When this occurs, the X-ray tube does not receive sufficient cooling, and the system displays a "TUBE HOT, have a break" message. Several minutes later, the system automatically blocks X-ray function and displays "NO XRAY: TUBE TOO HOT" to prevent equipment damage.
The recall affects specific serial numbers listed in the recall notice, which can be identified using the UDI 4056869010069. The source document does not specify what actions affected consumers or facilities should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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".
Reason for recall: 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". Distribution: US Nationwide. Quantity: 373 systems Lot/code info: 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 153946 153145 154801 154683 153829 153148 131021 153878 153906 153959 131208 131104 153709 153119 153217 154565 154653 154671 154556 154406 154518 155126 153164 153304 154778 153869 153634 154685 153719 153232 131101 131005 153770 154633 154020 153930 153355 154058 153811 154684 153225 154155 153875 155203 153289 153790 153102 154708 153963 154579 154762 153824 154034 154018 153356 154560 155131 155191 154596 153701 153113 153235 153347 153708 153338 154066 131223 153706 153259 154663 153314 154544 1
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.