Siemens recalls AXI: A dedicated x-ray system that may unintentionally expose patients to low radiation levels during rare unpressed exposure events. Affected units have serial numbers starting with 1192.
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 x-ray system because it can occasionally expose patients to very low radiation levels without the user pressing the exposure button. This risk is rare and the radiation dose is minimal, but the recall ensures safety.
The system can perform x-ray exposures without the exposure button being pressed, releasing radiation for less than 500ms. This results in a very low radiation dose (less than 0.01mSv) but may occur in rare situations.
Healthcare facilities using the Siemens AXIOM Aristos FX x-ray system with serial numbers starting with 1192 are most at risk. Patients undergoing scans with this system may be exposed to minimal radiation in rare cases.
Check for serial numbers starting with '1192' on the system. The product is a dedicated x-ray system with a flat panel detector used for whole-body imaging.
Look for the serial number on the system; affected units start with '1192'.
The system can occasionally expose patients to very low radiation levels without the exposure button being pressed, but the risk is rare and the radiation dose is minimal.
Check the serial number on the system; affected units start with '1192'.
The recall does not require immediate action, but you should check the serial number to confirm if your system is affected.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1764-2020 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1764-2020 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.
