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 Azurion 7 M20 is a medical imaging device used in interventional procedures to provide real-time X-ray imaging. Healthcare providers rely on this equipment for precise diagnostics and treatment planning.
The device's missing SSD spacer compromises the required radiation safety standards, potentially leading to harmful radiation exposure during procedures.
This recall is not part of a broader industry pattern.
The recall necessitates immediate action from healthcare providers to mitigate risks associated with potential radiation exposure, affecting operational workflow.
The model number can typically be found on the device's identification label or user manual.
Expect a refund or replacement processing time of 4-6 weeks after returning the device.
Keep records of your device purchase, including photos, receipts, and correspondence with Philips regarding the recall.
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.
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