Reported Mar 8, 2023 · Ongoing
Phoenix mKDR, 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, digital mobile diagnostic x-ray system
- Lot codes and dates
- UDI/DI 08436046003002
- Serial Numbers
PH00092PH00093PH00094PH00095PH00097PH00098PH00099PH00100PH00110PH00111PH00112PH00113PH00114PH00115PH00116PH00117PH00118PH00135PH00136PH00137PH00138PH00139PH00140PH00141PH00142PH00143PH00144PH00161PH00162PH00163PH00164PH00165PH00166PH00167PH00168PH00169PH00176PH00177PH00178PH00179PH00180PH00181PH00185PH00186PH00187PH00188PH00189PH00190PH00191PH00192PH00010PH00090PH00091
- Amount recalled
- 53 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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