Siemens AXIOM Aristos FX X-Ray System Recalled for Unintended Radiation
Siemens is recalling 314 AXIOM Aristos FX 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, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 314 units of the System AXIOM Aristos FX x-ray system worldwide. The recall is due to a defect where the system may perform x-ray exposures without the exposure button being pressed.
In rare cases, this malfunction can result in persons receiving a low dose of unintended radiation. The exposure is released for less than 500 milliseconds, and the overall dose is estimated at 0.01 mSv or less than 500 mGy in total. The system is a dedicated x-ray unit with a flat panel detector used for radiographic exposures of the whole body, including the skull, spinal column, chest, abdomen, and extremities, but excluding mammography.
The affected units are identified by serial number 1192. The recall is classified as Class II by the FDA. Users of these systems should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the defect.
The recalled product
- Product
- System AXIOM Aristos FX - Product Usage: 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. The MPRS allows radiographic exposures of the whole body including skull, spinal colum
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — X-Ray System
- Hazard
- Affected units
- 314
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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