Z-0805-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 20, 2021
- Initiation Date
- September 9, 2020
- Termination Date
- April 16, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6
Product Description
Uroskop Omnia, Model no. 10094910 - Product Usage: 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
After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm becoming dislodged in cases when the monitor support arm is used intensely over a long period of time.
Distribution Pattern
Worldwide distribution.
Code Information
Serial Nos. 3417 3414 3415 3418 3428 3416