Artis zee ceiling, Model Number 10094137
FDA Device Recall #Z-2029-2019 — Class II — June 12, 2019
Recall Summary
| Recall Number | Z-2029-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 12, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Siemens Medical Solutions USA, Inc |
| Location | Malvern, PA |
| Product Type | Devices |
| Quantity | 428 |
Product Description
Artis zee ceiling, Model Number 10094137
Reason for Recall
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
Distribution Pattern
US Nationwide Distribution
Lot / Code Information
Serial Numbers: 146669 146877 146996 146663 147100 146286 146292 146410 146676 147155 147049 147233 146406 146407 146411 146121 146710 146945 147084 147189 147190 146679 146766 146232 146408 146409 146728 146335 146659 146993 146898 146965 146221 147273 146814 146871 146952 147030 147239 146988 146899 146368 146643 146650 146980 146361 146365 146366 146369 146912 147036 146116 146164 146168 147079 147371 146156 146342 146343 147129 146192 147081 146235 146201 146260 146277 146868 146758 146818 146741 146174 147507 146245 147047 125002 146171 146173 146176 146186 146187 146188 146189 147042 146630 146266 146305 146908 146267 147208 147247 146219 146272 146274 147096 125022 147236 146193 146761 147175 146298 146637 146972 147078 146976 146652 146327 146333 146338 147786 147023 146851 147249 147255 146688 146166 146144 147165 147188 146324 146715 146293 146308 146968 147105 146825 146827 146828 146829 147304 146937 146946 147024 146334 125005 146322 146888 147172 146136 146738 146795 147164 146395 147378 147087 146742 146169 146856 146921 146263 146781 146721 146724 146860 146393 147035 125009 147193 147196 146986 146323 146150 146812 146241 146242 146635 147025 146354 147044 146251 146727 146238 146388 146382 147814 146753 146755 146756 147203 146119 146264 146618 147098 146139 147113 146656 147107 146942 146886 147167 146733 147121 146612 147106 146731 146809 146394 146846 146855 146940 146957 147243 146918 146709 147831 147119 147120 147124 146901 147144 147237 147240 146863 146934 146806 146935 147268 146798 147168 147029 125004 146619 146205 146803 147285 146722 146717 146774 146690 146691 146218 146987 146786 146424 146983 146152 146975 146137 146279 146289 146750 147296 147171 146184 147210 146775 146776 146969 146971 146973 147200 146345 147067 125016 147059 147177 146872 146784 146932 146397 147238 146887 147241 146711 147089 146233 146170 146220 146919 146257 147009 146183 147114 146839 146178 147214 147216 146963 147373 147123 146212 146895 146909 146627 146712 146740 147174 146713 146320 146175 146179 146181 146182 147083 146337 146861 146939 146696 146104 146948 146964 146729 146313 146158 146959 146147 146759 146779 146735 146991 146732 146857 146748 147088 146254 146631 146905 146111 146161 125003 146123 146197 147093 147264 147364 147075 125000 146869 147043 146623 146634 146960 146896 147027 146701 146703 146720 146747 146994 146370 146372 146373 146982 146386 146340 146217 147287 146256 146302 146341 146234 146667 147205 147250 147251 147252 147253 147254 146239 146933 146348 146697 146925 146929 146801 146719 146138 147363 147372 146692 146694 147157 146206 146391 146658 146357 146632 146927 147207 125015 147234 146883 146297 146352 146793 146915 146290 147295 146811 147046 146287 146326 146644 146944 146821 146833 146398 146427 146677 147307 146705 147103 147303 147265 147301 147235 146881 147094 146714 146107 146700 147031 146118 146149 146299 146698 146817 146797 146782 146977 146780 146928 147109 146155 146955 146140 146866 146867 147186
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.