Device product
Uroskop Omnia -fluoroscopic X-ray system Model # 10094910 The Uroskop Omnia is a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).
Z-0984-2019
Product summary
- Event
- Event 82211
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6
- Official record key
device-enforcement:Z-0984-2019
Official wording
Reason: The swivel arm holding the monitors may become dislodged from the carrying arm.
Code information: Serial Numbers: 3414 3415 3416 3417 3418 3428
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
The swivel arm holding the monitors may become dislodged from the carrying arm.