Siemens Medical Solutions USA, Inc: Medical Device Recall in 2026 - (Recall #: Z-0999-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 5, 2025

Date Posted: January 14, 2026

Recall Number: Z-0999-2026

Event ID: 98230

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.

Status: Ongoing

Product Quantity: U.S.: 1, OUS: 95

Code Information:

(01)04056869269931(21)10330

Distribution Pattern:

U.S. and OUS

Voluntary or Mandated:

FDA Mandated