Siemens Medical Solutions USA, Inc: Device Recall

Recall #Z-2527-2024 · 07/02/2024

Class II: Risk

Recall Details

Recall Number: Z-2527-2024
Classification: Class II
Product Type: Device
Recalling Firm: Siemens Medical Solutions USA, Inc
Status: Ongoing
Date Initiated: 07/02/2024
Location: Malvern, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 26 units

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

Product Description

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

Distribution Pattern

US Nationwide distribution.

Other Recalls by Siemens Medical Solutions USA, Inc

Class II: Risk 12/29/2025

Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
Class II: Risk 12/29/2025

Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
Class II: Risk 12/19/2025

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Class II: Risk 12/19/2025

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Class II: Risk 12/19/2025

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

View all recalls by Siemens Medical Solutions USA, Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.