FDA Enforcement
Class II
Ongoing
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.
Recall: Z-0781-2024
·
Reported January 31, 2024
Enforcement
- Recall Number
- Z-0781-2024
- Event ID
- 93614
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- SEDECAL SA
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 31, 2024
- Initiation Date
- December 13, 2023
- Classification Date
- January 22, 2024
- Address
- PELAYA, 9 POL., POL. IND. RIO DE JANEIRO, Algete, N/A, N/A, Spain
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
Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
Code Info
All serial numbers, UDI-DI 08436046002500.
Distribution
Distribution was made to AL, FL, and NC. There was no military/government distribution.
Quantity
845 units