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SEDECAL SA recalls Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm.
Recalled January 31, 2024 · FDA recall Z-0781-2024 · SEDECAL SA
Hazard
Some parts have fallen off the equipment resulting in a safety risk to patients and/or users. · FDA Class II
Units
845 units
Sold at
Distribution was made to AL, FL, and NC. There was no military/government distribution.
Description
Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
Product
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.
Manufacturer(s)
SEDECAL SA
Made in
Spain
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →