FDA recall Z-0806-2021

Siemens Medical Solutions USA, Inc · Class II · device

Product

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).

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.

Distribution

Worldwide distribution.

Key facts

Status
Terminated
Initiation date
2020-09-09
Report date
2021-01-20
Termination date
2021-04-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0806-2021