Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic…
Medical device recall Z-1165-2023. Published in FDA’s Enforcement Report on Mar 1, 2023.
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 Mar 1, 2023. 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
- 28 units. Expanded Recall: 506 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?
Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10762472
28 units. Expanded Recall: 506 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,998 characters
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…
FDA’s list runs to 2,651 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 Dec 21, 2022.
- FDA classified it on Feb 23, 2023.
- FDA’s Enforcement Report published it on Mar 1, 2023.
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: N/A.
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 2,651 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.