FDA-Device2020-02-26Class II
Uroskop Omnia max, Model No. 10762473 - Product Usage: Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system is designed primarily for urological diagnosis and the support of urological therapeutic applications such as examinations and small interventions of the urogenital tract.
Hazard
Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or persons when the operator uses the override function.
Sold states
US Nationwide distribution.
Affected count
192
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
Uroskop Omnia max, Model No. 10762473 - Product Usage: Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system is designed primarily for urological diagnosis and the support of urological therapeutic applications such as examinations and small interventions of the urogenital tract.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1333-2020More Siemens Medical Solutions USA, Inc recalls
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