Philips Medical Systems is recalling approximately 11,614 Azurion image-guided therapy systems, including models in the Azurion 3, 5, and 7 series. These medical devices are being recalled because the patient table may move unexpectedly when the Reset Geometry button is pressed, even if the table lock is active. This voluntary recall affects software versions R1.X, R2.X, and R3.X distributed worldwide.
Unexpected movement of the patient table during a procedure could cause physical injury to the patient or clinical staff, or interfere with delicate surgical tasks. No specific injuries have been reported in the current data, but the malfunction bypasses safety locks designed to keep the table stationary.
Recall #: Z-1344-2026; Quantity: 291 units
Recall #: Z-1345-2026; Quantity: 802 units; Model 722282 is OUS only.
Recall #: Z-1346-2026; Quantity: 655 units
Recall #: Z-1347-2026; Quantity: 1503 units
Recall #: Z-1348-2026; Quantity: 1979 units
Recall #: Z-1349-2026; Quantity: 5136 units; Model 722282 is OUS only.
Recall #: Z-1350-2026; Quantity: 326 units
Recall #: Z-1351-2026; Quantity: 922 units; Model 722281 is OUS only.
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.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.