Mar 3, 2026 FDA device enforcement
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Class II Reported ongoing
Distribution: Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia,...
Official source for ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027; Mar 3, 2026 FDA device enforcement
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Class II Reported ongoing
Distribution: Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia,...
Official source for ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028; Mar 3, 2026 FDA device enforcement
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Class II Reported ongoing
Distribution: Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia,...
Official source for ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013; Mar 3, 2026 FDA device enforcement
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Class II Reported ongoing
Distribution: Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia,...
Official source for ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035; Mar 3, 2026 FDA device enforcement
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Class II Reported ongoing
Distribution: Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia,...
Official source for ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025; Mar 3, 2026 FDA device enforcement
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Class II Reported ongoing
Distribution: Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia,...
Official source for ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033; Mar 3, 2026 FDA device enforcement
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Class II Reported ongoing
Distribution: Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia,...
Official source for Allura Xper FD20/10; System Code: 722029; Mar 3, 2026 FDA device enforcement
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Class II Reported ongoing
Distribution: Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia,...
Official source for Allura Xper FD20/20; System Code: 722038; Mar 3, 2026 FDA device enforcement
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Class II Reported ongoing
Distribution: Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia,...
Official source for Allura Xper FD20/20 OR Table; System Code: 722039; Mar 3, 2026 FDA device enforcement
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Class II Reported ongoing
Distribution: Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia,...
Official source for Allura Xper FD20/15; System Code: 722058; Mar 3, 2026 FDA device enforcement
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Class II Reported ongoing
Distribution: Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia,...
Official source for Allura Xper FD20/15 OR Table; System Code: 722059; Mar 3, 2026 FDA device enforcement
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Class II Reported ongoing
Distribution: Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia,...
Official source for Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229; Mar 3, 2026 FDA device enforcement
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Class II Reported ongoing
Distribution: Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia,...
Official source for Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only); Mar 3, 2026 FDA device enforcement
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Class II Reported ongoing
Distribution: Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia,...
Official source for Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235; Mar 3, 2026 FDA device enforcement
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Class II Reported ongoing
Distribution: Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia,...
Official source for Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236; Mar 3, 2026 FDA device enforcement
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Class II Reported ongoing
Distribution: Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia,...
Official source for Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233; Mar 3, 2026 FDA device enforcement
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Class II Reported ongoing
Distribution: Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia,...
Official source for Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only); Mar 3, 2026 FDA device enforcement
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Class II Reported ongoing
Distribution: Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia,...
Official source for Azurion 5 M12; System Code: (1)722227, (2)722231; Mar 3, 2026 FDA device enforcement
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Class II Reported ongoing
Distribution: Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia,...
Official source for Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only); Jan 26, 2026 FDA device enforcement
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Class II Reported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belg...
Official source for Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number -...