Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0999-2026 — LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471

U.S. FDA — Device Enforcement · United States · 2025-12-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0999-2026
Date of alert
2025-12-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Medical Solutions USA, Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04056869269931
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.