Philips Medical Systems Recalls Azurion 3 M15 System Due to Hazard
Philips Medical Systems Nederland B.V. recalled 802 Azurion 3 M15 systems on January 26, 2026. The systems may move unexpectedly, posing a risk to patients and healthcare providers. Consumers should stop using the device immediately and follow recall instructions.
Product Details
The recalled models include Azurion 3 M15 System Model Numbers: 722064, 722222, 722230, and 722280 (OUS only). Affected software versions include R1.X, R2.X, R3.X. The systems were distributed worldwide, with 45 units in the U.S. and 757 units in other countries.
The Hazard
The device may move unexpectedly when the Reset Geometry button is pressed, even if a table lock is active. This movement can lead to potential harm to patients during medical procedures.
Reported Incidents
There are no reported injuries or incidents associated with the recalled systems. The recall is classified as Class II due to its potential high hazard level.
What to Do
Stop using the Azurion 3 M15 system immediately. Contact Philips Medical Systems or your healthcare provider for further instructions on the recall.
Contact Information
For more information, contact Philips Medical Systems Nederland B.V. at their official website or the FDA's recall page.