FDAFDA · Food and drugs·Recall number Z-0805-2021
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).
Published January 20, 2021 · Recall initiated: September 9, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- Worldwide distribution.
- Lot
- Serial Nos. 3417 3414 3415 3418 3428 3416
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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