Siemens Medical Solutions USA, Inc: Device Recall

Recall #Z-0999-2026 · 12/05/2025

Class II: Risk

Recall Details

Recall Number: Z-0999-2026
Classification: Class II
Product Type: Device
Recalling Firm: Siemens Medical Solutions USA, Inc
Status: Ongoing
Date Initiated: 12/05/2025
Location: Malvern, PA, United States
Voluntary/Mandated: FDA Mandated
Product Quantity: U.S.: 1, OUS: 95

Reason for Recall

A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly between organ programs (OGPs) the collimation may be incorrect.

Product Description

LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471

Distribution Pattern

U.S. and OUS

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.