Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Sedecal X Optima URS digital mobile diagnostic x-ray system. A Recalled by SEDECAL SA Due to Some parts have fallen off the equipment resulting...

Date: December 13, 2023
Company: SEDECAL SA
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact SEDECAL SA directly.

Affected 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.

Quantity: 845 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 3 states: AL, FL, NC

Affected (3 states)Not affected

About SEDECAL SA

SEDECAL SA has 53 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report