Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355…
Medical device recall Z-2747-2018. Published in FDA’s Enforcement Report on Aug 22, 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 Aug 22, 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
- 605 units in 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?
Potential hardware issue which may cause thermal effects and possible damage to system parts.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage: Artis is a family of 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 with the Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis can also support the acquisition of position triggered imaging for spatial data synthesis.
605 units in total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model 10848280 - Serial Numbers: 103221 103061 103232 103217 103030 103218 103220 103013 103053 103039 103050 103008 103207 103222 103035 103230 103258 103001 103239 103263 103048 103028 103241 103212 103254 103255 103257 103245 103040…
Every code shown here, 1,996 characters
Model 10848280 - Serial Numbers: 103221 103061 103232 103217 103030 103218 103220 103013 103053 103039 103050 103008 103207 103222 103035 103230 103258 103001 103239 103263 103048 103028 103241 103212 103254 103255 103257 103245 103040 103253 Model 10848281 - Serial Numbers: 109033 109135 109141 109502 109123 109400 109344 109210 109080 109074 109417 109352 109388 109479 109418 109190 109191 109197 109198 109305 109405 109437 109119 109346 109419 109421 109016 109118 109493 109166 109496 109460 109137 109155 109379 109300 109187 109228 109327 109412 109066 109067 109068 109084 109133 109134 109365 109217 109366 109203 109011 109367 109169 109096 109159 109358 109202 109130 109490 109378 109384 109500 109451 109504 109505 109143 109431 109102 109445 109383 109407 109015 109211 109144 109413 109482 109332 109309 109488 109304 109168 109227 109467 109057 109221 109484 109401 109501 109162 109108 109485 109103 109165 109038 109040 109324 109457 109183 109034 109129 109181 109029 109136 109442 109064 109009 109194 109132 109226 109219 109321 109330 109058 109145 109050 109414 109380 109222 109224 109225 109076 109435 109386 109179 109432 109434 109007 109424 109188 109458 109229 109357 109071 109072 109075 109231 109355 109503 109091 109393 109090 109311 109041 109497 109164 109167 109039 109362 109060 109146 109429 109088 109373 109397 109426 109452 109364 109092 109032 109463 109415 109021 109461 109171 109048 109172 109301 109020 109036 109043 109326 109336 109480 109320 109163 109101 109104 109105 109107 109302 109369 109361 109186 109371 109069 109158 109047 109031 109027 109028 109318 109120 109402 109010 109093 109350 109232 109156 109157 109307 109308 109411 109349 109456 109391 109189 109214 109331 109044 Model 10848282 - Serial Numbers: 121185 121430 121406 121061 121195 121336 121089 121094 121169 121006 121013 121040 121368 121208 121445 121446 121062 121448 121082 121011 121039 121371 121134 121374 121053 121054 121422 121014 121112 121209 121325 121357…
FDA’s list runs to 4,164 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 Jun 22, 2018.
- FDA classified it on Aug 10, 2018.
- FDA’s Enforcement Report published it on Aug 22, 2018.
- FDA terminated it on Jan 15, 2020.
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 4,164 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.