Artis zee/ zeego systems
Medical device recall Z-1846-2015. Published in FDA’s Enforcement Report on Jul 1, 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 Jul 1, 2015. 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
- 475 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 exists a possible position sensor fault in the swivel base axis not being detected by the system software. When moving, the system could potentially exceed its usual speed, resulting in a collision. No injuries reported.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are 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. .
475, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
model numbers: 10094135 10094141 10094139 10094142 10094143 with serial numbers: 124002 154502 135746 153172 153315 153317 153318 137165 153992 153335 135120 137282 135322 153101 153102 154616 137226 153166 154536 135000 137103 137118…
Every code shown here, 1,999 characters
model numbers: 10094135 10094141 10094139 10094142 10094143 with serial numbers: 124002 154502 135746 153172 153315 153317 153318 137165 153992 153335 135120 137282 135322 153101 153102 154616 137226 153166 154536 135000 137103 137118 153700 154096 154454 137461 154715 135914 153834 154789 154779 153194 154532 157449 136085 158108 135927 137510 157136 154157 135209 153199 140106 154721 154722 137193 153887 157988 154571 153269 135935 135953 158091 135200 135201 135279 153191 153252 135169 135879 154612 153717 153239 157560 157509 157436 135990 153889 158132 137425 137479 153967 153236 154658 135229 137532 137540 154686 153273 153251 153254 153344 153342 140115 154567 154480 154093 153197 153171 136103 157448 137314 135862 157165 153831 135117 135358 153256 135920 137295 154704 153154 136168 135148 135939 153882 153311 135366 137075 154727 157977 157602 154408 153987 135843 157168 154053 153740 153709 137130 137188 153863 153772 140213 154509 137131 137146 137396 135137 153707 135309 157164 153263 153276 137388 158121 153758 137470 131013 124007 124015 157156 157975 157969 137347 137389 153245 137245 137335 153720 153998 153271 157573 157650 153939 153951 158080 135151 135421 130013 153290 135264 153678 153679 135199 135760 135217 137369 136031 136032 153277 154783 157928 137569 149402 136026 153743 154731 153946 135394 137119 135285 153145 136338 153868 157989 154683 153148 135245 154551 135420 157999 153767 154565 154653 154671 154556 154406 154518 154778 158066 154685 153719 135157 153232 135788 136113 131005 158032 154633 153257 158134 124039 137311 137320 137360 157524 135416 135129 135909 149202 135222 153355 153811 158058 153748 153883 153635 137521 154453 157992 135258 135260 136148 154708 136247 154579 135755 154762 153824 158079 135143 153356 154560 153718 154596 153701 137395 137093 158081 137018 158104 158105 135375 158056 153708 153338 149401 153248 137421 137551 135190 154663 137471 154544 137239 157965 137438 135881 137384 153988 137011 154614 124034…
FDA’s list runs to 3,405 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 May 22, 2015.
- FDA classified it on Jun 25, 2015.
- FDA’s Enforcement Report published it on Jul 1, 2015.
- FDA terminated it on Dec 13, 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 3,405 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.