The Artis zee / zeego Angiography System is designed as a set of components that may be combined into…
Medical device recall Z-0486-2015. Published in FDA’s Enforcement Report on Dec 10, 2014.
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 Dec 10, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 1131 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?
There is a potential issue on running Artis systems running software VC1x software if a network problem arises, the function cannot be deactivated again by pressing the "Block Radiation" key on the touch screen control. If this behavior occurs, the system image generation function is not available for patient examinations without switching the system off and back on again manually. This
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.
1131, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
model numbers: 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959 with serial numbers: 153229 153131 146669 146877 146996 157435 146663 147100 147233 147049 136077 135746 153172 135229 160313 146174 153315 153318 153317…
Every code shown here, 1,995 characters
model numbers: 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959 with serial numbers: 153229 153131 146669 146877 146996 157435 146663 147100 147233 147049 136077 135746 153172 135229 160313 146174 153315 153318 153317 146121 146710 146945 153992 147084 147189 147190 153335 153695 135120 135322 146679 153102 153101 146232 157660 153727 146728 146408 146409 157458 153216 146335 153779 146659 146993 153280 153648 153674 160395 153166 146898 146965 160484 135757 136513 153700 154096 135000 136562 146221 147273 157698 146871 146814 146952 147239 147030 135914 153834 146988 160348 157532 160502 146899 153194 153169 135102 146643 146650 136085 146980 146361 146365 146366 146369 146912 147036 135927 153110 146116 146164 146168 157657 160392 153890 157136 154157 153199 135209 140106 147371 153887 160115 146156 146342 146343 135986 153269 154074 157690 135935 135953 154012 147129 135841 153191 153252 135200 135201 135279 157616 153732 147210 135169 135879 160449 153274 157710 153717 153239 157560 157509 146192 157436 147081 160463 135990 154090 147267 153227 146235 153967 153655 146201 157677 153285 153234 153236 146249 146260 146277 146868 146818 146758 157528 146741 153273 153130 153129 153138 153686 146719 160139 153251 153254 146245 146217 153344 147047 157503 154095 160406 153342 140115 153328 146195 153106 153171 153197 153916 146187 146188 146189 136710 146113 146171 146173 146176 146186 146636 147042 157615 160134 160136 160106 146630 136103 157448 146766 135862 146266 157165 154086 146154 146298 146305 146908 153831 135235 135117 146267 147208 147247 135358 146219 146272 160338 146780 146274 153256 147096 160347 135920 153154 140101 147236 140205 136168 146193 146761 135148 157700 147175 153139 146637 135939 153882 146972 147078 160506 153311 135366 146327 146333 146338 153211 136568 147022 160312 147023 157602 146851 147249 147255 146410 146676 146248 146286 146292 135843 146688 146144 157168 154053 147188 147165 160488 135779 136224 153740…
FDA’s list runs to 8,014 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.
Worldwide Distribution - USA (nationwide) including Puerto Rico., and the countries of: United Arab Emirates, Armenia, Austria, Australia, Belgium, Bahrein ,Belarus, Switzerland, Chile, China, Colombia, Czech Republic,Germany, Denmark, Egypt, Spain, Finland, France, United Kingdom, Hong Kong, Hungary, Indonesia, Ireland, Israel, India, Italy, Jordan, Japan, Kenya, Korea, Kazakhstan, Malaysia, Netherlands, Norway, New Zealand, Philippines, Pakistan, Poland, Palestina, Portugal, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Turkey, Taiwan, Ukraine, Vietnam and South Africa.
The states and territories these words name
- Puerto Rico
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.
The words say it went outside the United States too.
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 Sep 11, 2013.
- FDA classified it on Nov 28, 2014.
- FDA’s Enforcement Report published it on Dec 10, 2014.
- FDA terminated it on Mar 30, 2015.
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 8,014 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.