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Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with ...

FDA Recall #Z-0781-2024 — Class II — December 13, 2023

Recall #Z-0781-2024 Date: December 13, 2023 Classification: Class II Status: Ongoing

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.

Reason for Recall

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

Recalling Firm

SEDECAL SA — Algete, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

845 units

Distribution

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

Code Information

All serial numbers, UDI-DI 08436046002500.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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