Radiography systems recalled because collimation may be incorrect between programs
Siemens Medical Solutions is recalling LUMINOS Lotus Max and Luminos dRF Max systems because switching quickly between organ programs may result in incorrect collimation.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites incorrect collimation under a specific operating sequence with no stated consequence or reported harm.
Plain-English summary
The LUMINOS Lotus Max, model 11574100, and Luminos dRF Max, model 10762471, are being recalled by Siemens Medical Solutions USA, Inc.
The record cites a potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems running software version VF11 with a bucky wall stand for mobile detectors and without a ceiling stand: when switching quickly between organ programs, the collimation may be incorrect.
The record lists 1 unit in the United States and 95 outside it, identified by (01)04056869269931(21)10330. Distribution was in the United States and outside it. The FDA has classified the action as Class II.
The record describes an incorrect collimation condition and states no further consequence or reported injuries. Facilities should follow Siemens' instructions.
The recalled product
- Product
- LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
- Manufacturer
- Siemens Medical Solutions USA, Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- (01)04056869269931(21)10330
Distribution
Distribution scope not specified by the agency.
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