Medical Device Recall: 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 po
SEDECAL SA · December 13, 2023
Reason for Recall
Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
Product Description
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.
Distribution
Distribution was made to AL, FL, and NC. There was no military/government distribution.
States Affected
AL, FL, NC
Quantity Affected
845 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0781-2024
Status: ongoing
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