Philips recalls Azurion 3 M12, 3 M15, 7 B12, 7 B20, 7 M12 and 7 M20 models (2016-2020) due to potential oil leakage in X-ray tube cooling units that may cause system to switch to low-dose fluoroscopy. No remedy provided.
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.
Philips is recalling certain Azurion X-ray systems (models 3 M12, 3 M15, 7 B12, 7 B20, 7 M12, and 7 M20) manufactured between February 2016 and May 2020. The deaeration hose in the X-ray tube cooling units may degrade over time, potentially causing oil leakage. This can lead to the system automatically switching to low-dose fluoroscopy mode with a warning message about tube cooler problems, which cannot be resolved by restarting the system.
The deaeration hose in the X-ray tube cooling units may degrade over time, leading to oil leakage. When oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy mode and displays a message about tube cooler problems. This condition cannot be resolved by restarting the system.
Healthcare facilities using Philips Azurion X-ray systems with the specified models and serial numbers are most at risk. The hazard is not expected to cause serious injury under normal use conditions.
Check if your Philips Azurion system has model numbers 3 M12 (722063), 3 M15 (722064), 7 B12 (722067), 7 B20 (722068), 7 M12 (722078), or 7 M20 (722079, 722223) manufactured between February 2016 and May 2020. The system will display a warning message about tube cooler problems if the deaeration hose has degraded.
Look for the model numbers listed above and verify the manufacturing date range
If your system displays a warning message about tube cooler problems, contact Philips for further instructions
The recall is for potential oil leakage in the X-ray tube cooling units, but it does not pose a serious injury risk under normal use conditions.
Check if your system has model numbers 3 M12 (722063), 3 M15 (722064), 7 B12 (722067), 7 B20 (722068), 7 M12 (722078), or 7 M20 (722079, 722223) manufactured between February 2016 and May 2020.
Contact Philips directly for further instructions as the system will automatically switch to low-dose fluoroscopy mode with a warning message about tube cooler problems.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-2227-2026 — Philips Philips Hello, I own a Philips that is covered by recall Z-2227-2026 from Philips. 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.
