Siemens Axiom Luminos dRF Max Recall for Software Data Loss
Siemens is recalling 133 Axiom Luminos dRF Max imaging systems due to a software defect that can cause acquired images to be deleted, requiring studies to be repeated.
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: The recall is classified as FDA Class II. The hazard involves data loss and the need to repeat imaging studies, which is a significant operational and clinical inconvenience but does not involve direct physical injury or death, fitting the Moderate severity criteria for low-risk contamination or operational defects without reported harm.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 133 units of the Axiom Luminos dRF Max, a universal diagnostic imaging system used for radiographic and fluoroscopic studies. The recall is due to a software defect in version VE10E that can cause acquired images and studies to be deleted. This issue may also result in sporadic connection problems with portable detectors (MAX wi-D, MAX mini) during image recovery.
The data loss can occur when users press the undo button on the RAD subtask card or the previous series button on the Image subtask card during image readout. It can also happen sporadically during automatic or manual RIS updates. As a result of this defect, medical acquisitions may need to be repeated.
The affected devices are distributed nationwide. The specific model number is 10762471, and the recall covers units with serial numbers 5043, 5085, 5069, 5086, 5037, 5072, 5049, 5039, and 5120. Healthcare facilities should contact Siemens to address the software issue and ensure data integrity.
The recalled product
- Product
- SIEMENS Axiom Luminos dRF Max, a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device i
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 133
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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