Agency classClass IIOur severity:High FDA (Devices)·Z-2755-2020·Announced 2020-08-12

Siemens Luminos dRF Max Recalled for Software Collision and Image Errors

Siemens is recalling 49 Luminos dRF Max units due to software defects that may cause system collisions or incorrect diagnostic images.

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. The hazard involves a risk of physical collision and diagnostic errors, which fits the 'High' severity criteria for risk-of-harm products where specific injury reports are not detailed in the source text.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 49 units of the Luminos dRF Max (Model 10762471) medical device. The recall is due to two software issues affecting the device and related systems. The first issue involves the override function, which may cause the system to collide with obstacles or persons if used when system movements are blocked. The second issue involves incorrectly assigned images, which may provide an incorrect basis for diagnosis when used with specific detectors.

The affected devices were distributed nationwide in the United States. The recall covers specific serial numbers listed in the agency's records. The Luminos dRF Max is intended to visualize anatomical structures by converting an X-ray pattern into a visible image.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve these software issues. The recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Imaging Equipment
Hazard: collision
diagnostic-error
Affected units: 49

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.

See all 4 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

See all →

Moderate
ARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
High
ARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
Moderate
ARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
High
ARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
High
ARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10

Same hazard · collision