PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R2.X, R3.X

Hazard

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

Details from the source

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. Distribution: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herz., Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Quantity: 655 units (106 US, 549 OUS) Lot/code info: System Model Numbers:(1)722067, (2)722225, (3)722235; UDI-DIs:(1)884838085350, (2)884838099265, (3)884838116788; Serial Numbers: All;

UPC codes

884838085350, 884838099265, 884838116788

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.