Recall Z-0805-2021— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0805-2021
Creator: U.S. Food and Drug Administration
Published: 2020-09-09

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2020-09-09, terminated 2021-04-16. It names one FDA 510(k) clearance: K101491. Product: Uroskop Omnia, Model no. 10094910 - 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: 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..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2020-09-09
Terminated: 2021-04-16
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, Model no. 10094910 - 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.

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