***Updated 12/4/23***
Medical device recall Z-0196-2024. 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
- ***Updated 12/4/23*** 186 units Cios Flow, 181 units Cios Spin 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?
***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment and provides comprehensive image acquisition modes. Material Number: 11108110 (2)Cios Spin- a mobile x-ray system designed to provide x-ray imaging of the anatomical structures of patients during clinical applications Material Number: 10308194
***Updated 12/4/23*** 186 units Cios Flow, 181 units Cios Spin, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
***Updated 12/4/23*** (1) UDI-DI: 04056869246628 S/N: 80006 80009 80010 80014 80017 80018 80019 80020 80021 80022 80023 80025 80026 80028 80031 80032 80033 80048 80051 80052 80053 80055 80059 80060 80063 80064 80065 80067 80068 80069 80071…
Every code shown here, 1,996 characters
***Updated 12/4/23*** (1) UDI-DI: 04056869246628 S/N: 80006 80009 80010 80014 80017 80018 80019 80020 80021 80022 80023 80025 80026 80028 80031 80032 80033 80048 80051 80052 80053 80055 80059 80060 80063 80064 80065 80067 80068 80069 80071 80072 80073 80074 80075 80080 80081 82010 82011 82012 82013 82028 82031 82036 82037 82038 82039 82040 82043 82044 82045 82046 82061 82075 82076 82079 82080 82089 82092 82095 82096 82097 82112 82123 82124 82131 82132 82139 82144 82157 82159 82160 82161 82162 82163 82172 82176 82177 82178 82182 82183 82193 82194 82196 82198 82199 82200 82203 82205 82206 82207 82215 82223 82226 82227 82229 82236 82239 83003 83004 83005 83007 83008 83011 83012 83013 83023 83027 83029 83030 83034 83035 83038 83039 83040 83041 83048 83052 83053 83060 83063 83064 83070 83074 83086 83093 83094 83100 83102 83104 83108 83110 83112 83114 83115 83116 83117 83126 83128 83134 83138 83140 83141 83143 83144 83154 83155 83161 83194 83196 83220 83228 83229 83233 83245 83246 83247 83249 83273 83281 83283 83285 83303 83307 83311 83356 83357 83373 83374 83376 83412 83425 83441 83449 83454 83456 83458 83465 83473 83476 83490 83491 83493 83497 83514 83515 2) UDI-DI: 04056869153506 Serial: 50030 50032 50033 50048 50050 50051 50072 50073 50075 50079 50081 50088 50094 50096 50098 50101 50107 50109 50111 50120 50122 50123 50124 50127 50129 50130 50131 50132 50135 50153 50155 50166 50171 50184 50185 50192 50198 50199 50200 50201 50209 50210 50211 50213 50214 50215 50216 50219 50222 50276 50282 50302 50311 50315 50426 50427 50429 50431 50444 52008 52011 52018 52019 52022 52023 52024 52026 52027 52028 52029 52030 52034 52036 52037 52050 52070 52075 52078 52082 52088 52091 52093 52104 52108 52110 52111 52113 52116 52117 52121 52122 52124 52127 52130 52132 52137 52139 52140 52147 53006 53007 53008 53010 53011 53012 53014 53018 53024 53027 53030 53033 53035 53038 53039 53040 53042 53045 53047 53048 53049 53050 53053 53056 53057 53065 53067 53071 53072 53080 53087 53089 53095…
FDA’s list runs to 2,289 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.
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.”
- FDA’s list of codes runs to 2,289 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.