FDA-Device2024-01-31Class II
Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It allows one to take exposures of patients in standing, sitting, or laying position.
SEDECAL SA
Hazard
Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
Sold states
Distribution was made to AL, FL, and NC. There was no military/government distribution.
Affected count
845 units
Manufactured in
PELAYA, 9 POL., POL. IND. RIO DE JANEIRO, Algete, N/A, Spain
Products
Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It allows one to take exposures of patients in standing, sitting, or laying position.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0781-2024Don't want to check this manually?
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