Recall Z-1000-2023— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1000-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-09

Class II · Ongoing

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2022-12-09. It names 2 FDA 510(k) clearances: K051602, K992660. Product: AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF. Reason: There is potential for the footrest to detach from the patient table during use..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Ongoing
Initiated: 2022-12-09
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K051602 — AXIOM SIRESKOP SDSiemens Medical Systems, Inc.·cleared 2005-07-07
K992660 — URF DIGITAL - OTSiemens Medical Solutions USA, Inc.·cleared 1999-11-05

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

AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF

Reason for recall

There is potential for the footrest to detach from the patient table during use.

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