Axiom Artis systems, dedicated angiography systems developed for single and biplane diagnostic imaging and…
Medical device recall Z-2342-2015. 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?
Axiom Artis 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: 7727717 7555357 7728392 5917054 7555373 7412807 7008605 7413078 7007755 7728350 5904649 5904433 5904656 5904441 serial numbers: 28151 14101 35143 35239 37701 46017 46022 46023 53181 40023 55163 55057 28100 40072…
Every code shown here, 2,000 characters
Model Number of device: 7727717 7555357 7728392 5917054 7555373 7412807 7008605 7413078 7007755 7728350 5904649 5904433 5904656 5904441 serial numbers: 28151 14101 35143 35239 37701 46017 46022 46023 53181 40023 55163 55057 28100 40072 44151 53104 53067 28021 40075 32099 32101 35456 10373 10407 10326 14095 46154 46107 55157 28108 44101 35327 53093 25209 35368 44246 46071 46072 25267 50063 35432 35690 44185 55304 10328 28119 53162 30002 35301 35451 35553 46263 25280 25163 55399 35427 35743 35750 35762 40012 46079 44262 53201 55435 55567 35778 35788 50059 10255 28070 35020 10235 10017 10142 25004 46134 46274 55407 55412 55310 25090 40000 10355 28117 28145 10366 10432 55395 35736 10338 25101 14111 53706 40015 35350 35369 55129 35158 25069 55120 55470 28144 50006 49006 35297 50187 50064 44263 10012 55164 55187 35019 35601 53098 35438 55091 46087 53066 44046 53016 50189 50044 10093 55059 25173 35664 35730 35783 55204 10340 28081 55008 55377 10129 28158 55307 46091 10123 10188 35376 35561 35714 46105 40031 46203 35547 46277 55102 35325 10305 28018 32029 35126 35131 35314 35522 44199 55171 55368 35061 55210 25178 55133 55135 55477 44195 50074 14096 14110 55250 10150 46025 44105 46014 46100 10248 32090 35333 14010 14017 28010 55100 53028 44075 44084 53188 14019 44041 44080 44072 28036 55318 46056 44243 44198 55196 55230 55277 44171 35136 35908 35909 46033 25077 49001 34999 55466 55423 53209 55015 10180 35511 44275 44104 55320 55387 55576 53083 10047 55161 55220 35536 35560 53094 55258 55385 10482 35329 25202 14057 44215 28066 55438 35655 35810 53223 10073 14037 35098 35335 55010 55046 10122 10300 32066 50101 35353 10099 46042 10424 35359 35410 35599 44021 44255 14073 55503 35361 35095 35113 35545 46256 55308 35283 53114 25230 10345 35828 55139 46063 51719 25061 10296 14033 55039 35114 55270 35610 50062 10266 35893 46036 53023 53167 35258 35374 50017 28159 25286 28045 55188 35042 35125 35351 35815 30004 30006 53063 25037 10477 46112 46115 10371 10210 55218 55314 50065 35613…
FDA’s list runs to 7,441 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 7,441 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.