Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern int...
FDA Device Recall #Z-2525-2024 — Class II — July 2, 2024
Recall Summary
| Recall Number | Z-2525-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 2, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Siemens Medical Solutions USA, Inc |
| Location | Malvern, PA |
| Product Type | Devices |
| Quantity | 333 units |
Product Description
Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762472
Reason for Recall
The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays
Distribution Pattern
US Nationwide distribution.
Lot / Code Information
UDI: (01)04056869009162(21) Serial Numbers; Serial Number 64144 61058 64374 64413 64433 64048 64460 64385 64036 64013 64448 64451 64445 64057 64205 64326 64055 64051 64262 64288 64338 64061 64131 64314 64399 64034 64443 64105 64019 64309 64325 61231 64032 64170 64088 64457 64478 64104 64244 64449 64316 64111 64280 64239 64241 64420 64412 64136 64273 64112 64247 64329 64124 64486 64196 64320 64388 64147 64446 64479 64290 64299 64397 64228 64117 64176 64327 64251 64098 64060 64441 64452 64100 64313 64082 64041 64035 64029 64110 64381 63388 64278 64444 64078 64191 64435 64331 64174 64377 64426 64300 64118 64333 64127 64257 64348 64281 64211 64382 64271 64149 64346 64464 64266 64199 64431 64179 64336 64396 64099 64090 64107 64172 64469 64180 64364 63386 64384 64238 64305 64484 64311 64221 64285 64204 64265 64408 64383 64154 64103 64483 64407 64470 64248 64021 64418 64334 64276 64252 64400 64120 64083 64150 64129 64053 64089 64058 64145 64141 64073 64347 64332 64471 64185 64193 64390 64393 64079 64222 64437 64246 64065 64328 64303 64080 64062 64069 64227 64242 64139 64152 64220 64143 64360 64292 64163 64337 64411 64160 63382 64054 64272 64064 64462 64417 64282 64343 64068 64259 64330 64355 64215 64256 64156 64439 64175 64293 64323 64250 64286 64212 64480 64409 64318 64047 64243 64267 64224 64071 64031 64380 64218 64352 64466 64130 64315 64161 64162 64184 64093 64277 64270 64481 64477 64166 64072 64043 64226 64183 64294 64126 64361 64306 64304 64158 64291 64322 64474 64386 64468 64368 64018 64223 64376 64342 64353 64317 64312 64027 64232 64066 64091 64363 64350 64076 64074 64356 64268 64458 64307 64039 63372 64203 64159 64146 64208 64210 64467 64135 64165 64392 64229 64324 64123 64022 64432 64157 64394 64406 64447 64345 64344 64490 64216 64308 64372 64373 64173 64164 64463 64351 64358 64391 64234 64283 64440 64087 64121 64012 64178 64370 64403 64028 64209 64040 64190 64405 64067 64438 64045 64202 64485 64410 64155 64371 64097 64070 64416 64125 64455 64182 64133 64428 64171 64302 64106 64387 64422 64354 64049 64015 64434 64454
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.