FDA recall Z-0999-2026

Siemens Medical Solutions USA, Inc · Class II · device

Product

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

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.

Distribution

U.S. and OUS

Key facts

Status: Ongoing
Initiation date: 2025-12-05
Report date: 2026-01-14
Voluntary/Mandated: FDA Mandated
Location: Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0999-2026