Cios Alpha, Model Number 10308191 Mobile X-ray system - Product Usage: The Cios Alpha is a mobile X-Ray…
Medical device recall Z-1298-2019. Published in FDA’s Enforcement Report on May 15, 2019.
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 May 15, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 39 states named
- 257 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?
Continuous operation at very high tube output may result in increased wear of the radiation emitting components. This may occur when tube voltages of 125 kV are used for a long period, e.g. 30 minutes or more of continuous use. As a result, risk of premature failure of the Monoblock and loss of imaging X-rays.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Cios Alpha, Model Number 10308191 Mobile X-ray system - Product Usage: The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients.
257, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 11294 11202 12006 12009 13098 13016 12823 13011 11163 13009 13059 12662 11032 11311 13007 11258 11379 11380 12530 12334 11376 12426 11336 11132 11295 13004 13121 11044 12859 11005 11333 11386 10076 12677 10115 11291 11056…
Every code shown here, 1,557 characters
Serial Numbers: 11294 11202 12006 12009 13098 13016 12823 13011 11163 13009 13059 12662 11032 11311 13007 11258 11379 11380 12530 12334 11376 12426 11336 11132 11295 13004 13121 11044 12859 11005 11333 11386 10076 12677 10115 11291 11056 11287 12319 12529 12617 12623 12657 12876 12886 13048 13050 13105 13109 13110 12848 12574 12597 12647 13002 12875 12810 10078 12306 12317 12874 11119 12576 12678 12513 12592 12490 12885 11200 11281 11283 12425 12023 13070 12396 12920 11285 11103 11105 11257 11074 12379 11013 10021 11330 11066 13012 10057 11143 11077 11319 11240 11349 13082 11098 12815 12339 11153 11372 10037 11328 13008 12308 10063 11106 12373 12584 11067 10082 12026 12027 11168 12492 10019 11317 10035 11198 12040 12307 12440 11165 12611 11094 11226 11370 12970 12377 12861 10089 11082 11080 11009 11018 10058 12321 12718 12004 12999 11378 11167 11248 12817 11306 11229 12028 11144 12313 12867 12868 12869 12870 12881 12887 12889 12894 11038 12320 12514 11352 12612 12811 12838 11243 11314 12626 11374 12899 12902 12884 11162 11292 12394 12498 12549 11120 11134 13062 13064 12494 12925 12526 11219 11220 11346 12993 12956 12562 12607 12025 12805 12046 11288 12816 11356 12620 11124 12557 12806 11251 12322 12323 12533 12504 13073 12958 11015 11016 12486 12515 12500 12835 11327 11246 12878 10096 12391 12622 12652 12891 11290 12416 12472 12496 12552 12946 10116 12578 12642 12873 12599 12813 11280 11035 12003 12732 12570 12855 13045 13049 12030 12655 12818 12819 11359 12314 12618 12809 13033 11338 12947 12948 11064 12842 12457 12460 12972 13107
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 in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, and WI.
The states and territories these words name
39 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Illinois
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- North Carolina
- Nebraska
- New Jersey
- New Mexico
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
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 Mar 18, 2019.
- FDA classified it on May 8, 2019.
- FDA’s Enforcement Report published it on May 15, 2019.
- FDA terminated it on Apr 16, 2020.
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
-
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.