Siemens Medical Solutions USA, Inc recalls LUMINOS Lotus Max
- Recalling company
- Siemens Medical Solutions USA, Inc
- Product
- LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Dec 5, 2025
- Reported
- Jan 14, 2026
- Distribution
- U.S. and OUS
- Status
- Ongoing
- Quantity
- U.S.: 1, OUS: 95
- Lot / codes
- (01)04056869269931(21)10330
- Company location
- Malvern, PA
- Recall type
- FDA Mandated
- Recall number
- Z-0999-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0999-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.