Philips North America recalled 110 Azurion 7 M20 interventional fluoroscopic X-ray systems on October 27, 2025. These devices were shipped without the necessary Source-to-Skin Distance (SSD) Spacer, violating FDA regulations. The absence of this spacer poses a serious health risk during fluoroscopy applications.
Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Philips North America or your healthcare provider for instructions. Notification method: N/A
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The recalled product is the Azurion R3.0, Model Number 722234, commercially known as Azurion 7 M20. It was distributed in the U.S. from July 2024 to June 2025.
The absence of the SSD spacer prevents the system from maintaining the required minimum source-skin distance of 38 cm. This condition increases the risk of radiation exposure to patients during standard fluoroscopy procedures.
No specific incidents or injuries have been reported related to this recall. The risk level is classified as high due to the potential for increased radiation exposure.
Stop using the Azurion 7 M20 X-ray system immediately. Contact Philips North America or your healthcare provider for further instructions.
For more information, visit the Philips North America website or call their customer service number.
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