Siemens recalls AXI: A dedicated x-ray system with flat panel detector that may emit low unintended radiation in rare cases. Affected units have serial number 1192. No action needed but monitor for unusual radiation exposure.
It was determined that in rare cases persons can receive low dose of unintended radiation. The system performed exposures without the exposure button being pressed. Exposure will be released for less than 500ms, therefore, the overall dose is estimated at 0.01mSv or less than 500 mGy in total.
Siemens is recalling its AXIOM Aristos FX Plus x-ray system due to rare instances of unintended radiation exposure. This could result in very low radiation doses (less than 0.01mSv) if the system activates without the exposure button being pressed. The risk is extremely low and does not require immediate action.
The system can activate and take x-ray exposures without the exposure button being pressed, releasing radiation for less than 500ms. This results in very low radiation doses (less than 0.01mSv) in rare cases.
Healthcare facilities using the Siemens AXIOM Aristos FX Plus x-ray system with serial number 1192 are most at risk. Patients receiving scans with this system may also be affected.
Check for the serial number 1192 on the system. This is the only specific identifier mentioned in the recall.
Look for the serial number 1192 on the system to confirm if it is affected.
The recall indicates a very low risk of unintended radiation exposure in rare cases, with doses estimated at less than 0.01mSv. This is considered low risk.
No action is required. The recall does not specify a need to stop using the system.
Check for the serial number 1192 on the system. This is the only specific identifier mentioned in the recall.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1765-2020 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1765-2020 from Siemens. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
