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
PH00202PH00203PH00204PH00205PH00206PH00207PH00208
- 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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