SEDECAL SA: Medical Device Recall in 2024 - (Recall #: Z-0781-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 13, 2023

Date Posted: January 31, 2024

Recall Number: Z-0781-2024

Event ID: 93614

Reason for Recall:

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

Status: Ongoing

Product Quantity: 845 units

Code Information:

All serial numbers, UDI-DI 08436046002500.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated