Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible…
Medical device recall Z-2525-2024. Published in FDA’s Enforcement Report on Aug 14, 2024.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Aug 14, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 333 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762472
333 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,996 characters
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…
FDA’s list runs to 2,055 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jul 2, 2024.
- FDA classified it on Aug 7, 2024.
- FDA’s Enforcement Report published it on Aug 14, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Siemens Medical Solutions USA, Inc, of Malvern, PA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,055 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.