SIEMENS Healthineers Luminos Agile Max
Medical device recall Z-2756-2020. Published in FDA’s Enforcement Report on Aug 12, 2020.
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 12, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 477 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?
Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collision of the system under operator control with obstacles or persons .(2) Incorrectly assigned image affecting Ysio Max, Luminos dRF Max and Luminos Agile Max systems with detector MAX Static causing incorrect base for diagnosis
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
SIEMENS Healthineers Luminos Agile Max Model: 10762472 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
477 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 61203 61751 61085 61755 61858 61786 61795 61034 61127 61602 61212 61053 61194 61699 61757 61752 61200 61738 61799 61875 61603 61624 61885 61848 61243 61606 61682 61087 61888 61052 61889 61226 61854 61079 61218 61110 61137…
Every code shown here, 1,996 characters
Serial Numbers: 61203 61751 61085 61755 61858 61786 61795 61034 61127 61602 61212 61053 61194 61699 61757 61752 61200 61738 61799 61875 61603 61624 61885 61848 61243 61606 61682 61087 61888 61052 61889 61226 61854 61079 61218 61110 61137 61123 61763 61621 61622 61623 61788 61798 61837 61892 61193 61700 61743 61652 61229 61045 61838 61239 61632 61190 61013 61659 61102 61724 61063 61054 61784 61213 61651 61056 61088 61146 61681 61678 61873 61720 61716 61027 61021 61145 61824 61050 61210 61211 61240 61227 61185 61779 61140 61181 61061 61158 61242 61074 61209 61075 61686 61094 61032 61769 61608 61711 61869 61169 61223 61083 61234 61660 61661 61849 61143 61670 61616 61723 61754 61684 61249 61691 61130 61668 61806 61717 61174 61740 61722 61777 61126 61255 61855 61015 61183 61046 61804 61731 61748 61845 61822 61863 61719 61829 61162 61125 61156 61713 61196 61028 61076 61787 61825 61683 61081 61758 61609 61618 61744 61111 61248 61704 61890 61656 61663 61636 61827 61159 61114 61635 61132 61112 61118 61253 61664 61177 61733 61040 61641 61646 61151 61238 61673 61831 61221 61832 61638 61207 61133 61695 61671 61631 61201 61833 61865 61148 61128 61625 61815 61236 61828 61810 61172 61839 61116 61168 61175 61662 61048 61171 61060 61649 61768 61042 61115 61813 61188 61191 61206 61708 61665 61746 61747 61862 61230 61667 61881 61113 61771 61044 61147 61096 61617 61035 61861 61134 61033 61066 61155 61224 61876 61847 61157 61634 61844 61178 61882 61883 61065 61801 61841 61874 61068 61069 61880 61674 61680 61830 61776 61736 61761 61186 61766 61783 61756 61772 61797 61793 61843 61614 61250 61251 61868 61219 61803 61753 61856 61107 61152 61093 61091 61014 61025 61208 61791 61256 61654 61173 61154 61189 61142 61165 61842 61734 61759 61718 61878 61840 61043 61781 61785 61601 61687 61647 61895 61897 61036 61669 61038 61739 61679 61857 61049 61022 61037 61098 61792 61215 61707 61153 61715 61894 61611 61120 61150 61633 61029 61884 61657 61887 61072 61812 61879 61819 61187 61693 61800 61727…
FDA’s list runs to 2,877 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?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 Jan 8, 2020.
- FDA classified it on Aug 5, 2020.
- FDA’s Enforcement Report published it on Aug 12, 2020.
- FDA terminated it on Jun 21, 2022.
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 2,877 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.