Approximately 110 Philips Azurion R3.0 systems (Model 722234), commercially known as Azurion 7 M20 with a FlexArm stand, were shipped without a Source-to-Skin Distance (SSD) Spacer. These interventional fluoroscopic X-ray systems were distributed between July 2024 and June 2025. The missing spacer is a safety component required to maintain a minimum distance of 38 cm between the X-ray source and the patient's skin. Healthcare facilities should contact Philips to arrange for the necessary hardware correction.
Without the SSD spacer, the X-ray source may be positioned too close to the patient during medical procedures. This increases the risk of excessive radiation exposure or skin burns to the patient.
Philips Reference C&R 2025-IGT-BST-016; Quantity affected: 110 units.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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