Siemens recalls Artis Q.zen biplane X-ray systems with model 10848355 due to risk of overheating and system shutdown if coolant level drops. Affected units have specific serial numbers listed in the recall notice.
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several minutes later the system will block X-ray to prevent further damage and display the message "NO XRAY: TUBE TOO HOT".
Siemens is recalling Artis Q.zen biplane X-ray systems with model number 10848355 because low coolant levels can cause the X-ray tube to overheat, leading to system shutdowns. This could disrupt medical imaging procedures and potentially cause delays in patient care.
If the coolant level in the cooling circuit drops below a certain level, the X-ray tube overheats and the system displays a warning message. After several minutes, the system blocks X-ray production to prevent damage and shows a shutdown message. This can interrupt medical imaging procedures.
Healthcare facilities using the Artis Q.zen biplane X-ray systems with model number 10848355 are most at risk. Patients and medical staff may experience delays in imaging procedures if the system shuts down unexpectedly.
Check for the model number 10848355 on the device. Affected units have specific serial numbers listed in the recall notice, including those added as of October 4, 2023.
Verify the coolant level in the cooling circuit to ensure it is above the threshold to prevent overheating.
The model number is 10848355.
Check the serial number against the list provided in the recall notice, which includes specific numbers added as of October 4, 2023.
The system displays a warning message "TUBE HOT, have a break" and then blocks X-ray production after several minutes to prevent damage, showing "NO XRAY: TUBE TOO HOT".
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-0980-2022 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-0980-2022 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.