Artis zee/ zeego systems
Medical device recall Z-2404-2015. Published in FDA’s Enforcement Report on Aug 26, 2015.
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 26, 2015. 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
- 586 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?
in case a system error occurs and the system enters the “Bypass Fluoro” mode while the X-ray locking function is active, the only way to exit the X-ray locking function, would be to either resolve the root cause of the system being in “Bypass Fluoro” or to restart the system.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
586, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Numbers of device: 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959 with serial numbers: 146669 153131 153229 146877 157435 146663 147100 147049 147233 136077 147189 147190 153695 157660 153727 157458 146335…
Every code shown here, 1,998 characters
Model Numbers of device: 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959 with serial numbers: 146669 153131 153229 146877 157435 146663 147100 147049 147233 136077 147189 147190 153695 157660 153727 157458 146335 146659 153779 146993 153280 153648 153674 160395 160484 135757 136513 136562 147273 157698 147030 147239 146988 160348 157532 160502 146899 135102 153169 146643 136042 153803 146361 146365 146366 146369 146116 146164 146168 153110 160392 147371 160115 135986 157690 154074 154012 147129 135841 153732 147210 160449 153274 157710 160463 146235 147267 153227 154090 153655 157677 153234 153285 157528 146741 147047 157503 154095 153328 146195 146113 146187 146189 146636 147042 157615 153106 153916 160134 160136 146630 146766 146154 146298 154086 135235 147208 147247 147096 160347 147236 140101 140205 147175 157700 153139 160506 136568 153211 147023 146851 147249 147255 160488 135779 136224 146355 147105 147304 157213 160455 136109 146334 160435 136607 136579 154098 154073 146888 147172 154076 160451 136280 136286 147164 146324 147357 147363 147365 135413 147378 154156 146357 146619 153351 135144 135145 136362 153112 153155 146856 146921 157750 135404 157579 146724 140209 136318 153857 147035 160493 153226 147193 147196 157671 146323 146812 157554 157555 146241 146242 146635 147025 157713 157521 153190 136234 146251 160391 146727 146238 146388 160470 147203 136500 147098 136515 147113 160447 160471 135124 135125 136084 147107 153125 153128 153134 153135 160481 157696 136479 147121 135179 160403 160404 146612 157488 153829 157644 157648 140219 160008 146846 136384 136387 136488 153217 135770 153639 153119 136550 147243 160438 136005 136063 146709 153164 153304 136256 135767 136408 136450 136508 136547 147124 160388 147144 147237 147240 153869 136242 136383 146935 157169 153357 147268 146798 157508 157510 153770 147168 154020 136517 160346 146353 136043 146706 160384 157588 146205 157601 153929 153930 136586 147285 146722 153728 140218 154058…
FDA’s list runs to 4,216 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.
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 Jun 30, 2015.
- FDA classified it on Aug 18, 2015.
- FDA’s Enforcement Report published it on Aug 26, 2015.
- FDA terminated it on Dec 5, 2016.
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 4,216 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.