Sedecal Soltus Battery Mobile X-Ray System
Medical device recall Z-0182-2023. Published in FDA’s Enforcement Report on Nov 16, 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 Nov 16, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- 36 states named in where it went
- 155 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?
Due to un-commanded movement of mobile x-ray unit.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500
155 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model: Soltus 450 Type / UDI-DI Code: 10451 /08436046002555 10451-1 / 08436046002562 10451-2 / 08436046002531 10451-3 / 08436046002548 Serial Numbers / UDI Codes: SLS000014 (01)08436046002555(240)10451(11)200700(21)SLS000014 SLS000038…
Every code shown here, 1,971 characters
Model: Soltus 450 Type / UDI-DI Code: 10451 /08436046002555 10451-1 / 08436046002562 10451-2 / 08436046002531 10451-3 / 08436046002548 Serial Numbers / UDI Codes: SLS000014 (01)08436046002555(240)10451(11)200700(21)SLS000014 SLS000038 (01)08436046002555(240)10451(11)200800(21)SLS000038 SLS000039 (01)08436046002555(240)10451(11)200800(21)SLS000039 SLS000040 (01)08436046002555(240)10451(11)200900(21)SLS000040 SLS000046 (01)08436046002555(240)10451(11)200900(21)SLS000046 SLS000048 (01)08436046002555(240)10451(11)201000(21)SLS000048 SLS000050 (01)08436046002555(240)10451(11)201000(21)SLS000050 SLS000051 (01)08436046002555(240)10451(11)201000(21)SLS000051 SLS000077 (01)08436046002555(240)10451(11)201100(21)SLS000077 SLS000078 (01)08436046002555(240)10451(11)201000(21)SLS000078 SLS000079 (01)08436046002555(240)10451(11)201100(21)SLS000079 SLS000080 (01)08436046002555(240)10451(11)201100(21)SLS000080 SLS000081 (01)08436046002555(240)10451(11)201100(21)SLS000081 SLS000082 (01)08436046002555(240)10451(11)201100(21)SLS000082 SLS000083 (01)08436046002555(240)10451(11)201100(21)SLS000083 SLS000084 (01)08436046002555(240)10451(11)201100(21)SLS000084 SLS000085 (01)08436046002555(240)10451(11)201100(21)SLS000085 SLS000086 (01)08436046002555(240)10451(11)201100(21)SLS000086 SLS000087 (01)08436046002555(240)10451(11)201100(21)SLS000087 SLS000088 (01)08436046002555(240)10451(11)201100(21)SLS000088 SLS000089 (01)08436046002555(240)10451(11)201100(21)SLS000089 SLS000090 (01)08436046002555(240)10451(11)201200(21)SLS000090 SLS000091 (01)08436046002555(240)10451(11)201100(21)SLS000091 SLS000092 (01)08436046002555(240)10451(11)201100(21)SLS000092 SLS000093 (01)08436046002555(240)10451(11)201100(21)SLS000093 SLS000094 (01)08436046002555(240)10451(11)201100(21)SLS000094 SLS000095 (01)08436046002555(240)10451(11)201100(21)SLS000095 SLS000096 (01)08436046002555(240)10451(11)201100(21)SLS000096 SLS000127 (01)08436046002555(240)10451(11)210400(21)SLS000127 SLS000128…
FDA’s list runs to 9,939 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.
U.S.: KY, WI, FL, DE, WV, CA, MO, NY, NC, AL, AR, MS, GA, IL, IA, TN, KS, KY, IN, HI, OH, WY, PA, NV, RI, UT, AZ, OK, MN, ME, MT, WA, VA, SD, MI, LA, and TX O.U.S.: N/A
The states and territories these words name
36 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- Nevada
- New York
- Ohio
- Oklahoma
- Pennsylvania
- Rhode Island
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
- Wyoming
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Aug 12, 2022.
- FDA classified it on Nov 4, 2022.
- FDA’s Enforcement Report published it on Nov 16, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- SEDECAL SA, of Algete, Spain.
- 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 9,939 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.