FDA-Device2021-01-20Class II
Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).
Siemens Medical Solutions USA, Inc
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.
Sold states
Worldwide distribution.
Affected count
281
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0806-2021Don't want to check this manually?
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