Z-0984-2019 Class II Terminated
FDA device recall Z-0984-2019 was initiated by Siemens Medical Solutions USA, Inc on February 8, 2019 and is designated Class II. Reason for recall: The swivel arm holding the monitors may become dislodged from the carrying arm. The recall status is terminated (terminated May 5, 2020). Affected quantity: 6.
Recall Details
- Product Type
- Devices
- Report Date
- March 13, 2019
- Initiation Date
- February 8, 2019
- Termination Date
- May 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6
Product Description
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).
Reason for Recall
The swivel arm holding the monitors may become dislodged from the carrying arm.
Distribution Pattern
US Nationwide Distribution
Code Information
Serial Numbers: 3414 3415 3416 3417 3418 3428