Recall Z-0984-2019— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0984-2019
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: K101491. 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: 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

K101491 — UROSKOP OMNIASiemens Medical Solutions USA, Inc.·cleared 2010-06-30

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 -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.

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