SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System
Medical device recall Z-2758-2020. 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
- 512 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 Ysio Max - Interventional Fluoroscopic X-Ray System, Model: 10762470 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
512 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 24576 24077 25409 24100 24213 24051 24531 24542 24038 24116 25699 25698 25089 25076 25297 25477 25056 24644 24221 25717 25647 25716 24256 24572 25366 25425 25020 24616 24275 25444 24433 24536 24340 24437 24033 25392 25006…
Every code shown here, 1,996 characters
Serial Numbers: 24576 24077 25409 24100 24213 24051 24531 24542 24038 24116 25699 25698 25089 25076 25297 25477 25056 24644 24221 25717 25647 25716 24256 24572 25366 25425 25020 24616 24275 25444 24433 24536 24340 24437 24033 25392 25006 25554 25506 25644 25666 25164 25619 25156 25677 25038 25151 25152 24401 25125 25093 24291 25369 24622 24624 24629 24630 24635 24636 24637 24640 25375 24613 24244 24615 25672 24155 24159 24237 24066 24106 24343 25458 24381 24394 24402 25217 25192 25260 25669 24495 24502 24666 24430 24432 25629 25196 24052 25547 24128 24420 25600 24611 24450 24154 24156 25427 25154 25678 24059 24467 24612 24614 24505 25542 25098 25205 24299 25058 25246 24599 24600 25607 25371 25374 25380 25391 25397 25398 25404 24048 24099 25292 25250 24263 25569 25097 25105 24660 24662 25403 25416 25459 25497 24436 25414 25047 24113 25204 25109 24367 24463 24634 24641 25700 24028 24283 25558 24590 25351 25280 25448 24496 25124 25095 25171 25512 24197 25565 24288 24289 24046 25509 25312 25463 25305 25096 24312 24408 25645 25693 25715 24375 25104 25304 25510 25237 25244 25447 24190 24063 24284 24350 24441 24507 25694 25216 25082 25107 25060 24506 25077 25090 25053 25322 25389 25667 25668 25116 25440 25676 25679 25713 25714 24442 24440 25439 25424 25051 25357 24083 25664 24225 25342 25675 24357 25670 24135 24172 25568 24558 24560 24327 24591 25031 25604 25426 24300 24592 25023 24131 25085 25531 25613 25119 25191 25471 24427 24470 25696 25697 25638 25144 25493 25238 25402 24091 25370 24663 25456 25049 24174 25114 25315 24625 24546 24551 24201 25143 25147 25225 25014 25009 25412 25683 25075 25165 25546 25256 25634 25436 25328 25592 24024 24186 24187 25284 24656 24659 24574 25273 24543 25001 24504 24129 24277 25072 24103 24148 24424 24515 24571 24142 25199 24453 25228 25491 25492 25686 25219 25213 25240 25625 25695 25527 25587 25159 24480 25701 25501 25505 25507 25373 24304 25190 24214 25218 24082 25137 25691 25133 25655 25310 25673 25193 25517 25616 24478 25026 24182…
FDA’s list runs to 3,087 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 3,087 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.