Z-0781-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 31, 2024
- Initiation Date
- December 13, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 845 units
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.
Reason for Recall
Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
Distribution Pattern
Distribution was made to AL, FL, and NC. There was no military/government distribution.
Code Information
All serial numbers, UDI-DI 08436046002500.