Artis zee floor, Model Number 10094135
FDA Device Recall #Z-0967-2022 — Class II — February 23, 2022
Recall Summary
| Recall Number | Z-0967-2022 |
| 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 | 305 systems |
Product Description
Artis zee floor, Model Number 10094135
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: 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 136026 137425 136479 135285 136338 136196 135245 135420 124051 136384 136387 136488 136256 135767 136408 136508 135182 137650 137668 136242 136383 135788 136517 135406 136043 137311 137320 137360 138163 135129 135416 138004 135222 136393 124268 137639 135302 135260 137736 138194 124273 138325 138358 135143 137645 135114 137093 136350 138193 135253 135772 138201 138250 135190 124378 137591 137438 135881 136614 136567 138104 135714 137656 138119 124302 138147 137239 138005 136089 138367 138397 135180 135184 135922 124119 136314 124703 137296 138015 136190 136197 136254 137458 138070 135813 136970 137229 124388 135791 137112 137218 124080 138230 138266 136561 138268 136505 124006 137244 137231 124118 135793 138346 135132 135148 138180 138480 137513 138458 138513 139012 137217 137224 135723 124111 136126 136217 135847 135281 135373 135196 124344 136557 136558 124286 137511 136391 137297 135909 136143 137403 139023 138357 138381 135384 136582 138340 136345 138188 137567 136459 136518 124314 136290 135233 135353 136594 135203 124056 137667 137579 137551 138051 136137 138190 135397 137518 136278 Additional Serial Numbers as of 10/4/23: 136450 135352 124201 124089 136548 136568 124015 136607 136586 136555
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.