Use cautionMedical device recall · FDA · Published December 13, 2023
SEDECAL Sedecal X Optima URS X-Ray System Recall: Parts Falling Off Risk
SEDEC: Sedecal X Optima URS digital mobile diagnostic x-ray system with falling parts poses safety risk to patients and users. Recall details and action steps provided.
“SEDECAL Sedecal X Optima URS X-Ray System Recall: Parts Falling Off Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/56562-sedecal-sedecal-x-optima-urs-x-ray-system-recall-parts. Based on FDA recall #Z-0781-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0781-2024%22&limit=1).
SEDECAL SA voluntarily recalled its Sedecal X Optima URS digital mobile diagnostic x-ray systems on Dec. 13, 2023, after parts fell off the equipment, creating a safety risk to patients and users, according to the FDA.
How to tell if you have it
Brand: SEDECAL
Product: Sedecal X Optima URS digital mobile diagnostic x-ray system
Description: Stationary x-ray unit with a universal swivel arm
UDI-DI: 08436046002500
Quantity: 845 units
Distribution: AL, FL, and NC
The hazard
Some parts have fallen off the equipment resulting in a safety risk to patients and/or users, according to the FDA.
Context
GovInfoNow's records show SEDECAL SA has had six other recalls since Oct. 14, 2021. Other recent recalls of similar products include GE Optima XR220amx Mobile X-Ray System Recall (June 5, 2026), GE Optima XR200amx Mobile Radiography System Recall (June 5, 2026), and GE Optima XR240amx Mobile X-Ray System Recall (June 5, 2026).
How to tell if you have this one
The Sedecal X Optima URS digital mobile diagnostic x-ray system with serial numbers starting with 08436046002500 is affected. This model has a universal swivel arm for mobile x-ray use.
Brand
SEDECAL
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Equipment Security
Ensure the x-ray system is securely mounted and not loose before use.
Where it went and when
Where it was distributed
Distributed in 3 states.
Listed by the agency
Not listed
FDA distribution: “Distribution was made to AL, FL, and NC. There was no military/government distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Florida, North Carolina.
Recall timeline
FDA published this recall 49 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0781-2024 (December 13, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0781-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.