PlainRecalls
FDA Devices Moderate Class II Ongoing

Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762473

Reported: March 1, 2023 Initiated: December 21, 2022 #Z-1168-2023

Product Description

Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762473

Reason for Recall

Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values

Details

Units Affected
7 units; Exanded recall: 215 units
Distribution
US Nationwide distribution.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762473. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 7 units; Exanded recall: 215 units.
Why was this product recalled?
Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values
Which agency issued this recall?
This recall was issued by the FDA Devices on March 1, 2023. Severity: Moderate. Recall number: Z-1168-2023.