PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura Xper FD20/10; System Code: 722029;

Hazard

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Details from the source

Reason for recall: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. Distribution: Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Quantity: 85 units (20 US, 65 OUS) Lot/code info: System Code: 722029; UDI: 00884838059078; System Serial Number: 57, 7, 88, 56, 126, 94, 30, 31, 21, 97, 91, 110, 100, 63, 60, 55, 62, 129, 71, 36, 26, 49, 114, 128, 108, 103, 107, 81, 43, 52, 119, 118, 80, 78, 47, 106, 123, 96, 122, 127, 14, 101, 116, 102, 115, 19, 109, 120, 92, 69, 27, 46, 93, 50, 51, 124, 87, 20, 32, 104, 34, 45, 59, 79, 24, 70, 39, 66, 82, 75, 40, 33, 23, 25, 85, 37, 44, 58, 38, 61, 98, 53, 89, 35, 48;

UPC codes

00884838059078

Source

Official record: FDA (Device enforcement) ↗

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