FDA recall Z-0985-2019

Product

Uroskop Omnia Max -fluoroscopic X-ray system Model # 10762473 Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.

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-0985-2019