Artis zee biplane, Model Number 10094141
FDA Device Recall #Z-0970-2022 — Class II — February 23, 2022
Recall Summary
| Recall Number | Z-0970-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 23, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Siemens Medical Solutions USA, Inc |
| Location | Malvern, PA |
| Product Type | Devices |
| Quantity | 373 systems |
Product Description
Artis zee biplane, Model Number 10094141
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 Pattern
US Nationwide.
Lot / Code Information
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 155291 153988 154614 154048 155310 155132 154800 153716 154592 131261 131224 153922 154014 153870 153628 155195 153249 153860 153264 155312 155119 153157 153903 153908 153819 154087 131247 153914 154085 154471 154604 154606 155286 154687 131111 153156 154707 154877 154459 153697 131000 154581 153147 154546 153928 155121 153864 153159 153756 154052 153797 154028 154732 154709 155226 155227 154678 131108 153865 153640 153714 153736 153832 153913 131011 153348 155159 153220 153947 131106 131103 153657 153873 154430 153117 153299 131213 153109 153150 154501 154514 153898 153757 154859 154064 155343 154562 154585 154044 153111 153618 153689 153847 154770 154056 153999 154785 153732 153728 153682 153120 153122 155118 153763 153686 154100 153631 154082 153617 153327 154429 153180 153818 154007 153323 154055 154631 153694 153886 154576 153186 154067 131020 155235 131262 154584 153270 154610 153862 131260 153607 153760 153265 153332 153343 153975 154476 153993 153325 153251 153254 131231 155150 154739 153684 153799 154041 155147 153952 153206 154602 154097 131252 153115 154572 131235 154564 154884 153744 153827 153671 Additional Serial Numbers as of 10/4/23: 154453 154094 131006
Other Recalls from Siemens Medical Solutions USA, Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1175-2026 | Class II | Interventional Fluoroscopic X-Ray System: LUMIN... | Dec 29, 2025 |
| Z-1174-2026 | Class II | Interventional Fluoroscopic X-Ray System: LUMIN... | Dec 29, 2025 |
| Z-1241-2026 | Class II | NAEOTOM Alpha.Prime Software applications: s... | Dec 19, 2025 |
| Z-1240-2026 | Class II | NAEOTOM Alpha Software applications: syngo.C... | Dec 19, 2025 |
| Z-1239-2026 | Class II | SOMATOM X.ceed Software applications: syngo.... | Dec 19, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.