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Use caution Medical device recall · FDA · Published December 21, 2022

Siemens Luminos dRF Max: Risk of collision causing serious injury

Siemens recalls Luminos dRF Max imaging systems with software VE10, VF10, VF11 due to room configuration risks that could cause serious injury from collisions with walls or ceilings.

🇺🇸 FDA recall #Z-1167-2023Medical deviceSiemens ›
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Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355-1418
✎ GovInfoNow plain-language explainer

Siemens is recalling Luminos dRF Max diagnostic imaging systems with specific software versions because the default room configuration settings could cause the machine to collide with walls, ceilings, or objects, potentially injuring staff or patients. This recall affects systems sold with software versions VE10, VF10, or VF11. Read more at govinfonow.com/recall/59075-siemens-luminos-drf-max-risk-of-collision-causing-serious-injury.

Source Summary by GovInfoNow · govinfonow.com/recall/59075-siemens-luminos-drf-max-risk-of-collision-causing-serious-injury · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1167-2023

Cite this page

“Siemens Luminos dRF Max: Risk of collision causing serious injury.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59075-siemens-luminos-drf-max-risk-of-collision-causing-serious-injury. Based on FDA recall #Z-1167-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1167-2023%22&limit=1).

The FDA announced on Dec. 21, 2022, that Siemens Medical Solutions USA, Inc. is recalling Luminos dRF Max diagnostic imaging systems due to a potential collision hazard. The agency stated the risk stems from default room configuration parameters.

How to tell if you have it

  • Brand: Siemens
  • Product: Luminos dRF Max with software VE10, VF10, VF11
  • Model Number: 10762471
  • UDI: 4056869009162
  • Serial Numbers: 5037 through 8389 (including specific expanded list)

The hazard

The systems pose a potential risk of collision with the ceiling, wall, or objects. This may result in serious injury to staff or patients due to room configuration parameters being set to default values.

Context

GovInfoNow's records show Siemens Medical Solutions USA, Inc. has 182 other recalls on record since June 6, 2017. Recent similar recalls include the Siemens ARTIS icono Ceiling Monitor Recall (June 8, 2026), the Siemens ARTIS icono floor recall (May 20, 2026), and the Siemens ARTIS Pheno VE30A/VE40A recall (March 12, 2026). Other recent recalls of similar products include the GE Maxxus Nuclear Medicine Systems Recall (Dec. 10, 2025), the Philips Azurion 5 M12 System Software Recalls (Jan. 26, 2026), and the IMRIS ORT300 Operating Room Table Recall (Aug. 6, 2026).

How to tell if you have this one

Check if your Luminos dRF Max system has software versions VE10, VF10, or VF11. The system model number is 10762471 and serial numbers include the ranges listed in the recall notice.

  • Brand
    Siemens
  • Category
    Medical device
FDA recall event · 5 products

All 5 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US Nationwide distribution.
Recall numberProduct, codes & lotsQuantity
Z-1164-2023Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Number: 10502200; UDI: N/A S/N: 60040 60018 60223 60015 Expanded Recall 2/24/23: S/N: 60011 60037 60041 60043 60051 60055 60056 60062 60067 60071 60072 60075 60076 60081 60087 60089 60092 60093 60095 60103 60111 60114 60118 60133 60138 60140 60141 60143 60146 60155 60162 60171 60172 60173 60178 60183 60184 60186 60187 60188 60192 60194 60196 60204 60208 60214 60219 60220 60221 60225 60227 60228 60230 60231 60234 60238 60239 60255 60259 60262 60264 60267 60273 60274 60277 60279 60286 60404 60408 60409 60412 60413 60414 60416 60417 60423 60424 60425 60429 60433 60436 60440 60441 60445 60446 60450 60452 60459 60464 60465 60466 60469 604734 units. Expanded Recall: 93 units
Z-1165-2023Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10762472; UDI: N/A Serial Number 61624 61652 61659 63243 63344 64145 61664 61641 61631 61148 61171 61224 61776 61186 61014 61189 61142 61718 61036 61857 63268 61775 61078 61216 61818 61629 61067 63350 Expanded Recall 2/24/23: 61017 61021 61031 61033 61034 61037 61038 61040 61041 61045 61047 61055 61057 61059 61063 61065 61073 61074 61075 61077 61083 61094 61096 61097 61098 61099 61100 61101 61102 61112 61118 61120 61123 61125 61126 61129 61130 61131 61132 61133 61143 61152 61153 61157 61158 61160 61164 61165 61166 61168 61172 61174 61175 61177 61178 61184 61185 61191 61193 61195 61202 61203 61205 61208 61209 61210 61220 61224 61226 61230 61233 61237 61243 61245 61253 61258 61604 61606 61612 61616 61617 61618 61626 61632 61633 61639 61640 61649 61653 61654 61655 61657 61662 61664 61665 61666 61667 61671 61672 61675 61676 61678 61683 61687 61691 61700 61702 61704 61707 61708 61710 61719 61723 61724 61725 61729 61734 61736 61740 61746 61751 61753 61754 61756 61758 61761 61764 61765 61769 61772 61774 61782 61783 61784 61787 61788 61790 61793 61797 61798 61809 61811 61817 61822 61824 61826 61828 61832 61833 61835 61843 61844 61849 61852 61856 61859 61863 61874 61875 61878 61879 61882 61884 61887 61888 61889 61890 61892 61893 61894 61895 61897 63013 63014 63015 63016 63017 63020 63023 63025 63026 63027 63034 63037 63038 63043 63045 63047 63051 63054 63056 63057 63058 63064 63065 63067 63076 63077 63078 63083 63084 63086 63087 63089 63091 63096 63100 63106 63108 63110 63121 63123 63124 63127 63129 63132 63134 63135 63136 63137 63138 63142 63148 63149 63157 63159 63161 63162 63164 63165 63171 63175 63176 63179 63185 63186 63188 63190 63192 63193 63194 63195 63196 63201 63203 63209 63210 63214 63218 63220 63223 63225 63228 63234 63236 63237 63238 63245 63246 63250 63253 63259 63260 63264 63266 63271 63279 63280 63289 63290 63292 63294 63296 63297 63300 63302 63303 63309 63315 63316 63318 63319 63324 63331 63332 63345 63346 63359 63361 63362 63371 64017 64023 64038 64042 64043 64046 64048 64051 64054 64055 64059 64061 64064 64074 64076 64078 64081 64083 64090 64097 64099 64106 64110 64111 64112 64117 64118 64120 64122 64123 64124 64134 64140 64141 64146 64148 64155 64157 64158 64159 64163 64164 64165 64166 64171 64174 64176 64177 64185 64186 64188 64189 64190 64193 64194 64199 64200 64201 64206 64207 64208 64209 64210 64211 64213 64215 64217 64224 64225 64226 64231 64233 64235 64238 64239 64240 64241 64244 64250 64254 64255 64256 64258 64259 64260 64261 64262 64264 64265 64266 64267 64268 64271 64272 64273 64274 64276 64277 64278 64279 64280 64281 64282 64283 64284 64285 64286 64287 64288 64289 64290 64291 64292 64294 6429828 units. Expanded Recall: 506 units
Z-1166-2023Luminos dRF with software VD10- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10094200; UDI: N/A S/N: 4650 Expanded Recall 2/24/23: 4043 4051 4143 4156 4199 4201 4238 4252 4291 4323 4332 4342 4354 4372 4401 4430 4508 4600 4606 4637 4641 4683 4722 4724 47341 unit; Expanded Recall: 25 units
Z-1167-2023Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762471; UDI: 4056869009162 S/N: 5037 5951 Expanded Recall 2/24/23: 5069 5085 5209 5234 5340 5364 5634 5664 5682 5919 5920 5921 5947 5953 5954 5956 5963 7075 7098 7147 7162 7168 7172 7208 7266 7310 7319 7391 7404 7442 7460 7488 7545 7743 7771 8074 8093 8094 8183 8198 8223 8242 8244 8275 8320 8322 8334 8361 8371 8378 8385 83892 units; Expanded recall: 53 units
Z-1168-2023Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762473; UDI: 4056869008981 S/N: 4645 4556 4510 5144 4307 4594 4125 Expanded Recall 2/24/23: 4014 4015 4020 4022 4032 4033 4042 4047 4055 4059 4061 4062 4063 4067 4068 4086 4094 4096 4099 4102 4105 4106 4108 4111 4112 4114 4117 4119 4120 4126 4128 4129 4130 4132 4134 4135 4136 4141 4142 4146 4303 4305 4306 4310 4312 4314 4316 4318 4319 4325 4326 4329 4330 4332 4500 4501 4509 4513 4516 4519 4520 4529 4531 4532 4535 4537 4538 4540 4541 4543 4544 4548 4552 4553 4554 4557 4559 4561 4562 4565 4566 4570 4575 4580 4582 4585 4587 4588 4591 4593 4597 4600 4601 4602 4603 4605 4609 4616 4626 4627 4629 4630 4631 4635 4636 4637 4641 4651 4659 4660 5026 5028 5030 5031 5033 5049 5051 5061 5062 5064 5066 5069 5072 5074 5078 5084 5088 5093 5101 5103 5107 5108 5112 5114 5116 5118 5123 5124 5128 5130 5133 5134 5135 5137 5139 5140 5142 5146 5152 5159 5163 5173 5174 5175 5186 5187 5190 5191 5196 5197 5198 5199 5208 5215 5221 5222 5232 5240 5258 5267 5268 5278 6013 6021 6023 6034 6035 6038 6039 6043 6044 6048 6050 6054 6062 6064 6065 6066 6069 6072 6078 6079 6080 6085 6090 6091 6096 6113 6120 6121 6127 6129 6131 6134 6136 6141 6146 6149 6154 6157 6163 6165 6168 6169 61767 units; Exanded recall: 215 units
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify your system's software version by checking for VE10, VF10, or VF11.

  2. Contact Siemens

    Reach out to Siemens for guidance on whether your system needs adjustment or correction.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Dec 21, 202212. FDA classified it Class II: Feb 23, 202323. Published in FDA’s Enforcement Report: Mar 1, 2023320222023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1167-2023 (December 21, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1167-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA