Artis Pheno, Interventional Fluoroscopic X-Ray System
Medical device recall Z-1294-2022. Published in FDA’s Enforcement Report on Jul 6, 2022.
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 6, 2022. 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
- 136 systems 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?
A video signal from one of the transceivers of the Large Display may be lost. In very rare cases, both transceivers of the Large Display could potentially fail which can lead to the loss of both video signals. This issue can sporadically affect the Large Display in the examination room as well as the displays in the control room.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000
136 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: 04056869046877 Serial numbers: 164140 164138 164159 164331 164332 164033 164287 164282 164210 164183 164184 164311 164142 164312 164071 164328 164034 164318 164244 164306 164155 164340 164189 164271 164277 164173 164292 164231…
Every code shown here, 1,012 characters
UDI-DI: 04056869046877 Serial numbers: 164140 164138 164159 164331 164332 164033 164287 164282 164210 164183 164184 164311 164142 164312 164071 164328 164034 164318 164244 164306 164155 164340 164189 164271 164277 164173 164292 164231 164095 164057 164054 164055 164132 164329 164072 164190 164048 164333 164025 164026 164027 164338 164094 164241 164326 164267 164186 164068 164121 164157 164019 164152 164161 164013 164069 164213 164073 164257 164293 164263 164298 164060 164083 164113 164021 164066 164362 164124 164125 164366 164279 164075 164074 164084 164086 164098 164028 164153 164330 164172 164295 164353 164234 164321 164242 164270 164275 164315 164344 164163 164158 164053 164171 164297 164134 164253 164188 164063 164064 164299 164300 164105 164160 164024 164080 164049 164240 164359 164227 164228 164018 164022 164250 164061 164187 164115 164011 164204 164205 164211 164212 164216 164100 164097 164269 164303 164322 164196 164355 164352 164168 164319 164201 164202 ***Updated 9/13/23*** 164088 164193
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.
Domestic distribution nationwide. Foreign distribution to Australia Austria Belgium Brazil Canada China Colombia Denmark Finland France Germany Hungary Indonesia Iran Italy Japan Kuwait Mexico Monaco Netherlands Norway Poland Singapore Slovakia South Africa Spain Sweden Switzerland Taiwan Thailand Turkey United Arab Emirates United Kingdom United States Vietnam
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.
The words say it went outside the United States too.
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 Jun 10, 2022.
- FDA classified it on Jun 27, 2022.
- FDA’s Enforcement Report published it on Jul 6, 2022.
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.”
- 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.