Siemens AXIOM Aristos FX Plus X-Ray System Recalled for Unintended Radiation
Siemens is recalling 399 AXIOM Aristos FX Plus x-ray systems worldwide because they may perform exposures without the button being pressed, resulting in low-dose unintended radiation.
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 involves a risk-of-harm product (unintended radiation exposure) where injury has not yet been reported, which aligns with the High severity criteria for medical devices.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 399 units of the System AXIOM Aristos FX Plus, a dedicated x-ray system with a flat panel detector, due to a defect that may cause unintended radiation exposure. The system is designed for whole-body radiographic exposures, including the skull, spinal column, chest, abdomen, and extremities, and is not intended for mammography use.
The recall was initiated because, in rare cases, the system may perform x-ray exposures without the exposure button being pressed. When this occurs, the exposure is released for less than 500 milliseconds. The overall dose from these unintended exposures is estimated to be 0.01 mSv or less than 500 mGy in total.
The affected units were distributed worldwide. Siemens is the recalling firm for this Class II recall. Users of these systems should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the defect.
The recalled product
- Product
- System AXIOM Aristos FX Plus - A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems; and allows radiographic exposures of the whole body including skull, spinal column, chest, abdom
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — X-Ray System
- Hazard
- Affected units
- 399
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- serail number 1192
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 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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