Siemens Artis zee systems
Medical device recall Z-2340-2015. Published in FDA’s Enforcement Report on Aug 12, 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 12, 2015. Copied from openFDA on Oct 20, 2026.
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?
The possibility exists for a large amount of liquid to seep through the top cover of the table and penetrate the components inside the table. If this occurs, table movements may no longer be possible. No injuries reported.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Siemens Artis zee systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
How much: “N/A”, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Number of device: 10094141 10094143 10094137 10094135 10094142 10848280 10280959 10848283 10848353 serial numbers: 146669 153131 153229 160851 146877 146996 146663 147100 124002 147049 147678 146406 146407 146411 136077 154502 135746…
Every code shown here, 1,997 characters
Model Number of device: 10094141 10094143 10094137 10094135 10094142 10848280 10280959 10848283 10848353 serial numbers: 146669 153131 153229 160851 146877 146996 146663 147100 124002 147049 147678 146406 146407 146411 136077 154502 135746 153172 153315 153317 153318 160879 146121 146710 137165 146945 147084 153992 147189 147190 153335 153695 135120 135322 146679 153101 153102 146232 147573 154616 153727 146408 146409 146728 146335 146659 153779 146993 137226 153280 153648 153674 160395 146898 153166 154536 146965 160484 135757 136513 135000 137103 146221 153700 154096 147273 154454 146814 146871 135914 146952 147030 147239 146988 153834 160348 147677 160502 160351 146899 153194 135102 147562 153169 154532 146643 136042 153803 160817 105007 147608 146650 136085 146980 146361 146365 146366 146369 146912 135927 147036 146116 146164 146168 153110 147581 147604 160392 153890 154157 135209 153199 140106 137193 153887 160115 146156 146342 146343 154571 135986 153269 154074 135935 135953 154012 147129 135841 135200 135201 135279 153191 153252 153732 147210 135169 135879 154612 160449 147636 153274 160834 160852 153717 153239 146192 147081 160463 135990 146235 147267 153227 153889 154090 153967 146201 153655 160823 146249 146260 146277 146868 153234 153236 153285 146758 146818 146741 160313 135229 146174 154686 160411 153273 146245 153251 153254 153344 147047 160406 125002 147667 147679 153342 140115 153328 147685 154567 146195 154480 154093 146113 147042 153106 153171 153197 160106 160134 160136 146171 146173 146176 146186 146187 146188 146189 146636 117001 146630 147630 136103 146766 135862 146266 146154 146298 154086 146305 146908 153831 135235 135117 146267 147208 147247 135358 146219 146272 147096 153256 160347 135920 147515 147236 153154 140101 140205 136168 160886 146193 135148 146761 147175 153139 146637 135939 146972 153882 147078 160961 160506 135366 146327 146333 146338 153311 147786 136568 153211 137075 160312 147023 160845 146851 147249 147255 147514 146410…
FDA’s list runs to 9,017 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
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 29, 2015.
- FDA classified it on Aug 5, 2015.
- FDA’s Enforcement Report published it on Aug 12, 2015.
- FDA terminated it on Dec 7, 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 9,017 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
-
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.