Class 2 Device Recall Luminos Agile Max

• Date Initiated by Firm: July 02, 2024
• Date Posted: August 07, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2525-2024
• Recall Event ID: 94948
• 510(K)Number: K173639
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762472
• 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
• FEI Number: 2240869
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 40 Liberty Blvd; Malvern PA 19355-1418
• For Additional Information Contact: SAME; 610-219-4834
• Manufacturer 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
• FDA Determined Cause: Under Investigation by firm
• Action: Siemens issued Customer Safety Advisory Notice (CSAN) XP017/24/S to Director of Diagnostic Imaging and/ or Radiology Laboratory on 7/2/24. Letter states reason for recall, health risk and action to take: Please visually inspect the mounting screw on the ceiling tube (Figure 1) or wall tube (Figure 2) of the display suspension as far as this is possible from the floor. In case the visual inspection of the mounting screw does not show any abnormalities, you can continue to use the system. Nevertheless, until the system has been checked by Siemens Healthineers customer service with the planned field action, we recommend: - not to swivel the support arm of the display ceiling/wall suspension to the mechanical limit with great force and - to ensure that there is no one under the display ceiling/wall suspension when positioning the displays. This Customer Safety Advisory Notice (XP017/24/S) is being distributed to all potentially affected customers. Siemens Healthineers is preparing a field safety corrective action that will be provided with Update XP018/24/S starting in the third quarter of 2024. The corrective action will involve check and replacement of the attachment of the support arm for the display ceiling/wall suspension by a service technician in an onsite visit. In instances where the mounting screw is broken, the support arm will also be replaced with update XP019/24/S. These field actions will be provided to you free of charge. Once the corrective actions are available, our customer service team will contact you to schedule an appointment to perform the above safety corrective action(s). Once the updates are available and if you would like to make an earlier appointment, please feel free to contact customer service at 1-800-888-7436. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Customer Safety Advisory Notice. Please respond within 14 days of receiving this notification
• Quantity in Commerce: 333 units
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OWB