Recall Z-0140-2014— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0140-2014
Creator: U.S. Food and Drug Administration
Published: 2013-09-03

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2013-09-03, terminated 2015-03-09. It names 2 FDA 510(k) clearances: K101491, K062623. Product: Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version VD10A/G Image intensified Fluoroscopic X-ray system. Reason: When using systems operating with software versions VD10A/G during a RAD examination, a malfunction can result in radiation continuing longer than required resulting in an overexposed image that is not of diagnostic quality, prompting repetition of the examination..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2013-09-03
Terminated: 2015-03-09
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K101491 — UROSKOP OMNIASiemens Medical Solutions USA, Inc.·cleared 2010-06-30
K062623 — AXIOM LUMINOS DRFSiemens Medical Solutions USA, Inc.·cleared 2007-08-22

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

Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version VD10A/G Image intensified Fluoroscopic X-ray system

Reason for recall

When using systems operating with software versions VD10A/G during a RAD examination, a malfunction can result in radiation continuing longer than required resulting in an overexposed image that is not of diagnostic quality, prompting repetition of the examination.

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