Siemens Medical Solutions USA recalled LUMINOS Lotus Max and Luminos dRF Max systems on December 5, 2025. The recall affects systems with software version VF11 and involves a potential collimation error. Healthcare providers and patients must stop using the devices immediately.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Siemens Medical Solutions USA, Inc or your healthcare provider for instructions
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The recalled products include LUMINOS Lotus Max (Model 11574100) and Luminos dRF Max (Model 10762471). The systems were distributed in the U.S. and internationally, with a total of 96 units recalled.
The recall stems from a software issue that may cause incorrect collimation when switching between organ programs. This error can lead to potential misdiagnoses or improper imaging.
No injuries or deaths have been reported related to this defect. The recall has been classified as Class II due to the potential for serious consequences.
Stop using the affected devices immediately. Contact Siemens Medical Solutions USA, Inc. or your healthcare provider for further instructions.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0999-2026.
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