Medical Device

Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X

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

Brand / Firm

Product

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

326 units (10 US, 316 OUS)

Description

Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X