PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — recalls
57 recall record(s) involving PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., from official U.S. government sources.
Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions anAzurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-Nicol (722030), IntegAllura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura XPhilips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230),Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intendedAzurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);Allura Xper FD20/20 OR Table; System Code: 722039;ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;Allura Xper FD20/15; System Code: 722058;Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;Azurion 5 M12; System Code: (1)722227, (2)722231;Allura Xper FD20/15 OR Table; System Code: 722059;Allura Xper FD20/10; System Code: 722029;ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033;Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);ALLURA Xper FD10F; System Code: 722002;Allura Xper FD20/20; System Code: 722038;ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);Vue Motion V12. Product Number: 1017979.Allura Xper FD10C; System Code: 722001;Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Number - All versions:Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - AlAzurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, RAzurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.XAzurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number -Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All versions: R1.X, R2.Philips Azurion system; Software Version Number: R3.1;Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. MAllura Xper FD20; Model Number: 722012;Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresAllura Xper FD10; Model Number: 722003;Product Name: Allura Xper FD10C; Model number: 722001;Allura Xper FD20/10; Model Number: 722029;Allura Xper FD10/10; Model Number: 722027;Allura Xper FD10/10; Model Number: 722005;Allura Xper FD10/10; Model Number: 722011;Allura Xper FD20 Biplane; Model Number: 722008;Allura Xper FD10; Model Number: 722026;Allura Xper FD10F; Model Number: 722002;Allura Xper FD20 Biplane; Model Number: 722013;Allura Xper FD20/20; Model Number: 722038;Allura Xper FD20; Model Number: 722006;Allura Xper FD20 OR Table; Model Number: 722023;Allura Xper FD20; Model Number: 722028;Allura Xper FD10; Model Number: 722010;Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;