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.
Z-0781-2024
Product summary
- Firm
- SEDECAL SA
- Event
- Event 93614
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 845 units
- Official record key
device-enforcement:Z-0781-2024
Official wording
Reason: Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
Code information: All serial numbers, UDI-DI 08436046002500.
Distribution pattern: Distribution was made to AL, FL, and NC. There was no military/government distribution.
Derived failure modes
-
Unknown
Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.