FDA-Device2023-03-08Class II
Phoenix mKDR Xpress, digital mobile diagnostic x-ray system
SEDECAL SA
Hazard
Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.
Sold states
US, Argentina, Panama
Affected count
7 units
Manufactured in
PELAYA, 9 POL., POL. IND. RIO DE JANEIRO, Algete, N/A, Spain
Products
Phoenix mKDR Xpress, digital mobile diagnostic x-ray system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1203-2023Don't want to check this manually?
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