PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura Xper FD20/20; System Code: 722038;

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: 111 units (31 US, 80 OUS) Lot/code info: System Code: 722038; UDI: 00884838054226; System Serial Number: 71, 115, 42, 108, 173, 119, 60, 37, 38, 99, 130, 48, 157, 41, 141, 137, 49, 63, 35, 167, 55, 70, 39, 62, 46, 118, 67, 78, 120, 7, 106, 102, 169, 11, 89, 117, 40, 105, 113, 110, 5, 134, 88, 64, 112, 143, 94, 109, 73, 166, 147, 31, 3, 127, 92, 135, 32, 69, 121, 123, 98, 129, 79, 14, 148, 153, 122, 164, 111, 160, 171, 172, 159, 155, 144, 163, 152, 168, 161, 158, 156, 138, 162, 132, 95, 116, 45, 9, 150, 146, 90, 27, 91, 154, 104, 124, 30, 136, 72, 93, 66, 140, 75, 50, 68, 58, 54, 47, 36, 170, 29;

UPC codes

00884838054226

Source

Official record: FDA (Device enforcement) ↗

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