Medical Device

Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number - All versions: R1.X,

Recall date: 2026-02-18 · Source: FDA_DEVICE

Brand / Firm

Product

Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X

Reason for recall

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

Units affected

802 units (45 US, 757 OUS)

Description

Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X