Artis Q Interventional Fluoroscopic X-Ray System
Medical device recall Z-3189-2018. Published in FDA’s Enforcement Report on Sep 26, 2018.
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 Sep 26, 2018. 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
- 429 total 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?
Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. This unintentional system behavior may occur while the unit is powered down for long periods (e.g. at night).
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355
429 total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
103221 103061 103217 103030 103218 103220 103013 103053 103039 103050 103008 103207 103222 103035 103001 103048 103028 103212 103040 109033 109135 109141 109123 109344 109210 109080 109074 109352 109388 109190 109191 109197 109198 109305…
Every code shown here, 1,995 characters
103221 103061 103217 103030 103218 103220 103013 103053 103039 103050 103008 103207 103222 103035 103001 103048 103028 103212 103040 109033 109135 109141 109123 109344 109210 109080 109074 109352 109388 109190 109191 109197 109198 109305 109119 109346 109016 109118 109166 109137 109155 109379 109300 109187 109228 109327 109066 109067 109068 109084 109133 109134 109365 109217 109366 109203 109011 109367 109169 109096 109159 109358 109202 109130 109378 109384 109143 109102 109383 109015 109211 109144 109332 109309 109304 109168 109227 109057 109221 109162 109108 109103 109165 109038 109040 109324 109183 109034 109129 109181 109029 109136 109064 109009 109194 109132 109226 109219 109321 109330 109058 109145 109050 109380 109222 109224 109225 109076 109386 109179 109007 109188 109229 109357 109071 109072 109075 109231 109355 109091 109393 109090 109311 109041 109164 109167 109039 109362 109060 109146 109088 109373 109364 109092 109032 109021 109171 109048 109172 109301 109020 109036 109043 109326 109336 109320 109163 109101 109104 109105 109107 109302 109369 109361 109186 109371 109069 109158 109047 109031 109027 109028 109318 109120 109010 109093 109350 109232 109156 109157 109307 109308 109349 109391 109189 109214 109331 109044 121185 121061 121195 121336 121089 121094 121169 121006 121013 121040 121368 121208 121062 121082 121011 121039 121371 121134 121374 121053 121054 121014 121112 121209 121325 121357 121051 121004 121167 121369 121133 121200 121163 121364 121314 121018 121154 121351 121354 121151 121036 121205 121340 121365 121137 121324 121012 121049 121078 121216 121333 121183 121019 121352 121165 121010 121148 121171 121139 121081 121210 121215 121366 121109 121323 121370 121096 121332 121015 121344 121115 121309 121204 121305 121016 121342 121301 121190 121315 121138 121372 121355 121193 121020 121179 121188 121161 121140 121168 121106 121321 121120 121121 121122 121144 121047 121312 121201 121088 121027 121359 121136 121141 121322 121069 121175 121173…
FDA’s list runs to 2,988 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 Jul 29, 2018.
- FDA classified it on Sep 18, 2018.
- FDA’s Enforcement Report published it on Sep 26, 2018.
- FDA terminated it on May 17, 2019.
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 2,988 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.