# FDA recall Z-0999-2026

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2025-12-05.

## 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

- **Recall number:** Z-0999-2026
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-05
- **Report date:** 2026-01-14

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Malvern, PA, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-0999-2026. Retrieved 2026-09-08 from https://api.ai-analytics.org/recall/Z-0999-2026. Source: US FDA. Licensed CC0.

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