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Recall Observatory FDA recall evidence

Device 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.

Z-0781-2024

December 13, 2023

Class II

Product summary

Firm
SEDECAL SA
Event
Event 93614
Status
Ongoing
Classification
Class II
Quantity
845 units
Official record key
device-enforcement:Z-0781-2024

Official wording

Reason: Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.

Code information: All serial numbers, UDI-DI 08436046002500.

Distribution pattern: Distribution was made to AL, FL, and NC. There was no military/government distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.