FDA Medical devices recall ·
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471 recall
- Recall number
- Z-0999-2026
- Date
- (initiated December 5, 2025)
- Company / brand
- Siemens Medical Solutions USA, Inc
40 Liberty Blvd, Malvern, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- U.S.: 1, OUS: 95
- Hazard tags
- Software
- Initiated by
- FDA Mandated
Read the official FDA notice ↗
Product
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
(01)04056869269931(21)10330
Distribution
U.S. and OUS
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0999-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.