Recall Z-0985-2019— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0985-2019
Creator: U.S. Food and Drug Administration
Published: 2019-02-08

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2019-02-08, terminated 2020-05-05. It names one FDA 510(k) clearance: K173639. 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: The swivel arm holding the monitors may become dislodged from the carrying arm..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2019-02-08
Terminated: 2020-05-05
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K173639 — Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom RaxSiemens Medi Cal Solutions, Inc.·cleared 2018-04-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.