Siemens Luminos Agile Max Recalled for Software Collision and Image Errors
Siemens Medical Solutions is recalling 477 Luminos Agile 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 with persons or obstacles and incorrect diagnostic images, which fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 477 units of the SIEMENS Healthineers Luminos Agile Max (Model 10762472) X-ray imaging device. The recall is due to two identified software issues affecting the device and related systems.
The first issue involves the override function used when system movements are blocked. On Luminos dRF Max, Luminos Agile Max, and Uroskop Omnia Max systems, this function may cause the system to collide with obstacles or persons under operator control. The second issue involves incorrectly assigned images on Ysio Max, Luminos dRF Max, and Luminos Agile Max systems equipped with the detector MAX Static, which may result in an incorrect base for diagnosis.
The affected units were distributed nationwide in the United States. Siemens Medical Solutions USA, Inc. is the recalling firm. Users should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected.
The recalled product
- Product
- SIEMENS Healthineers Luminos Agile Max Model: 10762472 - 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 — X-ray Imaging
- Affected units
- 477
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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