Artis zee ceiling-interventional Fluoroscopic X-Ray System
Medical device recall Z-1495-2021. Published in FDA’s Enforcement Report on May 5, 2021.
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 May 5, 2021. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 772 units U.S. 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?
Some Artis zee ceiling systems show an increased abrasion of the cabling at the cable outlet of the inner C-arm, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137
772 units U.S., in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 125000 125001 125002 125003 125004 125005 125006 125008 125009 125010 125011 125013 125015 125016 125017 125019 125021 125022 125023 125024 125100 125105 125106 125108 125109 125112 125113 125115 125116 125117 125118 125119…
Every code shown here, 1,997 characters
Serial Numbers: 125000 125001 125002 125003 125004 125005 125006 125008 125009 125010 125011 125013 125015 125016 125017 125019 125021 125022 125023 125024 125100 125105 125106 125108 125109 125112 125113 125115 125116 125117 125118 125119 125201 125202 125204 125205 125208 125209 125210 125211 125212 125213 125214 125216 125219 125222 125223 125226 125227 125228 125229 125230 125231 125232 125233 125235 125238 125239 125240 125241 125243 125244 125245 125249 125250 125251 125253 125254 125255 125256 125257 125260 125262 125263 125265 125267 125268 125269 125270 125273 125274 125275 125276 125278 146104 146107 146111 146116 146118 146119 146121 146123 146130 146136 146137 146138 146139 146140 146144 146147 146149 146150 146152 146156 146158 146161 146164 146166 146168 146169 146170 146173 146174 146175 146176 146178 146179 146181 146183 146184 146186 146187 146188 146189 146193 146197 146205 146206 146212 146217 146218 146219 146220 146232 146233 146235 146238 146239 146241 146242 146245 146251 146257 146260 146263 146264 146266 146267 146272 146274 146277 146279 146286 146287 146289 146290 146292 146293 146297 146298 146299 146305 146308 146313 146320 146322 146323 146324 146326 146327 146333 146334 146335 146338 146340 146341 146342 146343 146348 146352 146354 146357 146361 146365 146366 146368 146369 146370 146372 146373 146382 146386 146388 146391 146393 146394 146395 146397 146398 146406 146407 146410 146411 146424 146427 146612 146618 146619 146623 146627 146630 146631 146632 146634 146635 146637 146643 146644 146650 146652 146656 146658 146659 146663 146667 146669 146676 146677 146679 146688 146690 146691 146692 146694 146696 146697 146698 146700 146701 146703 146705 146709 146710 146711 146712 146713 146714 146715 146717 146719 146720 146721 146724 146727 146729 146731 146732 146733 146735 146738 146740 146741 146742 146747 146748 146750 146753 146755 146756 146758 146759 146761 146766 146774 146775 146776 146779 146780 146781 146782 146784 146786 146793…
FDA’s list runs to 5,419 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
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Mar 26, 2021.
- FDA classified it on Apr 26, 2021.
- FDA’s Enforcement Report published it on May 5, 2021.
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 5,419 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.