Recall Z-2527-2024— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-2527-2024
Creator: U.S. Food and Drug Administration
Published: 2024-07-02

Class II · Ongoing

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2024-07-02. It names one FDA 510(k) clearance: K173639. Product: LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 11574100. Reason: The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays.

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Ongoing
Initiated: 2024-07-02
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

LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 11574100

Reason for recall

The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays

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