Reported Mar 8, 2023 · Ongoing

Phoenix mKDR Xpress, digital mobile diagnostic x-ray system

Sedecal Sa

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: SEDECAL SA · PELAYA, 9 POL. · Algete, N/A · N/A

Is this the product you have?

  • Phoenix mKDR Xpress, digital mobile diagnostic x-ray system
Lot codes and dates
  • UDI/DI 08436046003163
  • Serial Numbers
    • PH00202
    • PH00203
    • PH00204
    • PH00205
    • PH00206
    • PH00207
    • PH00208
Amount recalled
7 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:42 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.