LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Summary
The FDA issued a Class II for LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471 by Siemens Medical Solutions USA, Inc. 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.
Details
Source
Device Recall
External ID
Z-0999-2026
Action Date
2026-01-14
Status
Ongoing
Category
device
Product Description
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Lot/Code Info: (01)04056869269931(21)10330
Quantity Affected: U.S.: 1, OUS: 95
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
Type: FDA Mandated
Recall Initiated: 2025-12-05
Company
Malvern, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 98 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Siemens Medical Solutions USA, Inc has 277 FDA actions in our database, including 173 recalls and 104 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Siemens Medical Solutions USA, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Siemens Medical Solutions USA, Inc have FDA actions?
Siemens Medical Solutions USA, Inc has 277 FDA actions in our database, including 173 recalls and 104 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0999-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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