PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); 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: 922 units (101 US, 821 OUS) Lot/code info: System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); UDI-DIs: (1)884838099234, (2)884838116757, (3)N/A; Serial Numbers: All;

UPC codes

884838099234, 884838116757

Source

Official record: FDA (Device enforcement) ↗

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