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).
Reported: January 20, 2021 Initiated: September 9, 2020 #Z-0805-2021
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.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 6
- Distribution
- Worldwide distribution.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
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).. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 6.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 20, 2021. Severity: Moderate. Recall number: Z-0805-2021.
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