FDA recall Z-0781-2024

SEDECAL SA · Class II · 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.

Reason for recall

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2023-12-13
Report date
2024-01-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Algete, N/A, Spain

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0781-2024