Siemens AXIOM Luminos dRF Max Systems Recalled for Image Loss Risk
Siemens is recalling AXIOM Luminos dRF Max systems due to malfunctions that cause lost images and incorrect labels, potentially leading to repeated examinations.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling Siemens AXIOM Luminos dRF Max systems due to two identified malfunctions that pose a potential risk to patients. The affected systems are intended for use as universal diagnostic imaging systems for radiographic and fluoroscopic studies.
The malfunctions cause lost images due to an automatic Radiology Information System (RIS) worklist update, which results in examinations being repeated. Additionally, image labels may be displayed incorrectly after images are acquired. These issues are associated with specific serial numbers.
The recall covers systems distributed nationwide in the US, including Utah, Missouri, Colorado, Massachusetts, Minnesota, Mississippi, Ohio, South Carolina, Michigan, and New York. Affected units include material number 10762471 with serial number 5037. Healthcare facilities should contact Siemens for further instructions on how to address these malfunctions.
The recalled product
- Product
- Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to be used as 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…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 1
Distribution
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.
See all 4 products in this recall →Related recalls
Same manufacturer · Siemens Medical Solutions USA, Inc
See all →- ModerateARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
- HighARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
- ModerateARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
- HighARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
- HighARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10
Same hazard · image loss
See all →- ModerateOlympus 4K UHD LCD Monitors Recalled Due to Potential Connector Faults
FDA (Devices) · 2026-07-29
- HighGlideScope Core 15-inch Monitor Software Issue Causes Potential Image Loss
FDA (Devices) · 2024-06-12
- HighGlideScope Core 15-inch Monitor Recalled for Potential Image Loss Software Issue
FDA (Devices) · 2024-06-12
- HighOlympus EVIS EXERA III Colonoscope Recall for Connector Defect
FDA (Devices) · 2023-12-06
- HighCanon Aplio Ultrasound Systems Software Defect May Misassign Patient Images
FDA (Devices) · 2022-11-16
Similar recalls
- ModerateSiemens Axiom Luminos dRF Max Recall for Software Data Loss
FDA (Devices) · 2015-06-03
- ModerateSiemens Axiom Luminos dRF Recalled for Fluid Infiltration Malfunction Risk
FDA (Devices) · 2014-09-24
- HighSiemens AXIOM Luminos dRFsystem Recalled for Electrostatic Discharge Risk
FDA (Devices) · 2014-06-11
- HighSiemens Luminos dRF Max Recalled for Software Bug Affecting Patient Images
FDA (Devices) · 2020-02-26
- HighSiemens Luminos dRF Max Recalled for Software Collision and Image Errors
FDA (Devices) · 2020-08-12
- HighSiemens Medical Imaging Systems Recalled for Potential Radiation Overexposure
FDA (Devices) · 2014-09-17