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.
What this means for you
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
- 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.
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