SEDECAL Soltus Battery Mobile X-Ray System: Uncommanded Movement Hazard
SEDECAL recalls Soltus 450 and 500 Battery Mobile X-Ray Systems due to uncommanded movement. Affected units have specific serial numbers and UDI codes. Stop using immediately to prevent potential injury.
Stop using this now
Due to un-commanded movement of mobile x-ray unit.
Contact the company
What happened, in plain English
SEDECAL is recalling Soltus 450 and 500 Battery Mobile X-Ray Systems because they can move unexpectedly while in use. This poses a risk of injury if the unit tips over or falls. Affected units have specific serial numbers and UDI codes listed in the recall. Read more at govinfonow.com/recall/60178-sedecal-soltus-battery-mobile-x-ray-system-uncommanded-movement-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/60178-sedecal-soltus-battery-mobile-x-ray-system-uncommanded-movement-hazard · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0182-2023
Cite this page
“SEDECAL Soltus Battery Mobile X-Ray System: Uncommanded Movement Hazard.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60178-sedecal-soltus-battery-mobile-x-ray-system-uncommanded-movement-hazard. Based on FDA recall #Z-0182-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0182-2023%22&limit=1).
Why it’s dangerous
The mobile x-ray unit can move unexpectedly during operation, which may cause it to tip over or fall. This poses a risk of injury to people in the vicinity, such as medical staff or patients.
Who’s affected
Healthcare facilities and medical professionals who use these mobile x-ray systems are most at risk. The uncommanded movement could cause the unit to tip over, potentially injuring people nearby.
How to tell if you have this one
Check if your unit has a serial number starting with SLS000002 to SLS000180 or a UDI code matching the listed numbers. The Soltus 450 and 500 models are affected.
- Brand
SEDECAL- Product
Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500- Category
Medical device
What to do — step by step
Stop Using Now
Immediately stop using the affected mobile x-ray unit to prevent potential injury from uncommanded movement.
Where it went and when
Where it was distributed
Distributed in 36 states.
FDA distribution: “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” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arizona, Arkansas, California, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0182-2023 (August 12, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0182-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.