FDA recall Z-0984-2019

Product

Uroskop Omnia -fluoroscopic X-ray system Model # 10094910 The Uroskop Omnia is 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

The swivel arm holding the monitors may become dislodged from the carrying arm.

Distribution

US Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2019-02-08

Report date

2019-03-13

Termination date

2020-05-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0984-2019