Use caution Medical device recall · FDA · Published February 6, 2023

SEDECAL Phoenix mKDR Xpress X-ray System Recall: Erratic Movements Risk

SEDECAL recalls Phoenix mKDR Xpress digital mobile diagnostic x-ray systems due to reported erratic movements. Affected units have specific serial numbers and UDI/DI codes. Consumers should contact SEDECAL for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1203-2023Medical device SEDECAL ›

Use caution until it’s fixed

Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.

Take action

Contact the company

Recalling firmSEDECAL SAPELAYA, 9 POL., POL. IND. RIO DE JANEIRO · Algete, Spain

✎ GovInfoNow plain-language explainer

SEDECAL is recalling Phoenix mKDR Xpress digital mobile diagnostic x-ray systems after reports of erratic movements. This could lead to unsafe operation of the x-ray system, potentially causing injury or damage. Read more at govinfonow.com/recall/58950-sedecal-phoenix-mkdr-xpress-x-ray-system-recall-erratic-movements.

Source Summary by GovInfoNow · govinfonow.com/recall/58950-sedecal-phoenix-mkdr-xpress-x-ray-system-recall-erratic-movements · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1203-2023

Cite this page

“SEDECAL Phoenix mKDR Xpress X-ray System Recall: Erratic Movements Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58950-sedecal-phoenix-mkdr-xpress-x-ray-system-recall-erratic-movements. Based on FDA recall #Z-1203-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1203-2023%22&limit=1).

SEDECAL SA voluntarily recalled seven Phoenix mKDR Xpress digital mobile diagnostic x-ray systems on Feb. 6, 2023, the FDA said. The recall addresses erratic movements reported in three incidents.

How to tell if you have it

Brand: SEDECAL
Product: Phoenix mKDR Xpress, digital mobile diagnostic x-ray system
UDI/DI: 08436046003163
Serial Numbers: PH00202, PH00203, PH00204, PH00205, PH00206, PH00207, PH00208

The hazard

Sedecal was informed of three incidents involving erratic movements related to the X-ray mobile systems.

Context

GovInfoNow's records show SEDECAL SA has six other recalls on record since Oct. 14, 2021. Other recent recalls of similar products include Philips Azurion X-Ray System Recall (June 17, 2026), Canon Alphenix INFX-8000C X-ray System Recall (Dec. 19, 2025), and Philips Azurion 7 B20 System Recall (Jan. 26, 2026).

How to tell if you have this one

Check for the serial numbers PH00202 through PH00208 or UDI/DI code 08436046003163 on the Phoenix mKDR Xpress x-ray system.

Brand
SEDECAL
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
US, Argentina, Panama

Recall number	Product, codes & lots	Quantity
Z-1202-2023	Phoenix mKDR, digital mobile diagnostic x-ray system; UDI/DI 08436046003002, Serial Numbers: PH00092, PH00093, PH00094, PH00095, PH00097, PH00098, PH00099, PH00100, PH00110, PH00111, PH00112, PH00113, PH00114, PH00115, PH00116, PH00117, PH00118, PH00135, PH00136, PH00137, PH00138, PH00139, PH00140, PH00141, PH00142, PH00143, PH00144, PH00161, PH00162, PH00163, PH00164, PH00165, PH00166, PH00167, PH00168, PH00169, PH00176, PH00177, PH00178, PH00179, PH00180, PH00181, PH00185, PH00186, PH00187, PH00188, PH00189, PH00190, PH00191, PH00192, PH00010, PH00090, PH00091	53 units
Z-1203-2023	Phoenix mKDR Xpress, digital mobile diagnostic x-ray system; UDI/DI 08436046003163, Serial Numbers: PH00202, PH00203, PH00204, PH00205, PH00206, PH00207, PH00208	7 units

Based on the official FDA remedy

What to do — step by step

Contact SEDECAL
Reach out to SEDECAL SA for specific instructions on how to address the recall.

How this recall unfolded

Recall timeline

FDA published this recall 30 days after the firm started it.

Feb 6, 2023Firm started the recall
Mar 2, 2023FDA classified it Class II
Mar 8, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/58950-sedecal-phoenix-mkdr-xpress-x-ray-system-recall-erratic-movements">SEDECAL Phoenix mKDR Xpress X-ray System Recall: Erratic Movements Risk (GovInfoNow)</a>

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-1203-2023 (February 6, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1203-2023 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.