FDAFDA · Food and drugs·Recall number Z-0781-2024
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.
Published January 31, 2024 · Recall initiated: December 13, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SEDECAL SA
- Distributor
- Distribution was made to AL, FL, and NC. There was no military/government distribution.
- Lot
- All serial numbers, UDI-DI 08436046002500.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Spain
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