Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment.…
Medical device recall Z-0195-2024. Published in FDA’s Enforcement Report on Nov 8, 2023.
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 Nov 8, 2023. 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
- 237 units 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?
Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patient misdiagnosis/repeat exposure
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200
237 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
***Updated 12/4/23*** UDI-DI: 04056869153490 S/N: 40013 40014 40015 40018 40020 40023 40030 40032 40033 40034 40035 40036 40039 40040 40046 40047 40048 40049 40050 40051 40052 40054 40055 40057 40058 40062 40070 40073 40075 40076 40077…
Every code shown here, 1,471 characters
***Updated 12/4/23*** UDI-DI: 04056869153490 S/N: 40013 40014 40015 40018 40020 40023 40030 40032 40033 40034 40035 40036 40039 40040 40046 40047 40048 40049 40050 40051 40052 40054 40055 40057 40058 40062 40070 40073 40075 40076 40077 40078 40080 40083 40084 40093 40094 40095 40102 40103 40104 40107 40108 40109 40110 40111 40116 40117 40119 40121 40122 40123 40124 40125 40126 40130 40134 40135 40137 40139 40157 40158 40160 40161 40162 40163 40164 40167 40168 40169 40170 40171 40174 40175 40176 40188 40189 40190 40191 40192 40193 40194 40196 40206 40208 40215 40220 40226 40228 40230 40231 40234 40236 40238 40239 40240 40242 40244 40245 40246 40248 40250 40251 40252 40255 40256 40257 40259 40261 40263 40264 40265 40266 40267 40268 40270 40271 40273 40276 40314 40315 40317 40318 40322 40323 40324 40336 40339 42001 42002 42003 42004 42005 42006 42010 42018 42024 42025 42028 42032 42033 42037 42040 42041 42042 42045 42046 42052 42057 42061 42068 42069 42082 42087 42094 42101 42111 42140 42141 42146 42147 42148 42156 42160 42161 42185 42186 42187 42188 42189 42190 42191 42196 42199 42202 43000 43002 43003 43006 43007 43013 43022 43023 43025 43026 43027 43028 43029 43031 43033 43034 43037 43042 43044 43045 43046 43048 43049 43055 43058 43060 43061 43062 43063 43072 43073 43076 43079 43086 43095 43105 43106 43108 43112 43142 43143 43150 43161 43163 43177 43193 43208 43222 43226 43231 43257 43261 43279 43283 43286 43289 43291 43296 43297 43298 43319 43339
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.
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?
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 Sep 12, 2023.
- FDA classified it on Oct 27, 2023.
- FDA’s Enforcement Report published it on Nov 8, 2023.
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.