Philips North America Llc: Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140;

Hazard

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Details from the source

Reason for recall: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. Distribution: Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Marti Quantity: 264 units (46 US, 218 OUS) Lot/code info: Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140; UDI-DI: (1) 00884838099715, (2) 00884838055322, (3) 00884838009820, (4) 00884838098275, (5) 00884838099043, (6) 00884838108646; Serial Numbers: (1) 61003, 61005, 61007, 61014, 61022, 61023, 61024, 61029, 61031, 61033, 61036, 61045, 61051, 61052, 61053, 61054, 61055, 61057, 61059, 61062, 61063, 61076, 61088, 61093, 61097, 61101, 61112, 61124, (2) 70009, 70042, 70051, 70056, 70059, 70075, 70095, 70104, 70203, 70223, 70249, 70257, 70262, 70300, 70311, 70346, 70376, 70381, 70383, 70427, 70432, 70439, 70440, 70453, 70460, 70461, 70472, 70483, 70588, 70596, 70598, 70619, 70645, 70646, 70647, 70650, 70658, 70659, 70661, 70672, 70684, 70699, 70702, 70708, 70712, 70724, 70736, 70741, 70751, 70798, 70800, 70820, 70825, 70826, 70836, 70846, 70862, 70863, 70880, 70886, 70889, 70896, 70897, 70902, 70920, 70922, 70953, 70961, 70970, 70975, 70977, 70979, 70983, 70988, 70989, 84027, 84031, 84034, 84042, 84043, 84076, 84079, 84080, 84084, 84085, 84093, 84118, 84130, 84136, 84141, 84157, 84170, 84172, 84173, 84185, 84186, 84191, 84193, 84202, 84203, 84205, 84210, 84212, 84226, 84233, 84253, 84266, 84267, 84270, 84276, 84281, 84295, 84332, 84333, 84335, 84343, 84359, 84360, 84376, 84379, 84388, 84394, 84416, 84419, 84429, 84431, 84448, 84462, 84484, 84485, 84487, 84507, 84509, 84528, 84539, 84545, 84549, 84550, 84555, 84560, 84568, 84596, 84628, 84634, 84635, 84641, 84654, 84694, 84708, 84713, 84721, 84722, 8

UPC codes

00884838099715, 00884838055322, 00884838009820, 00884838098275, 00884838099043, 00884838108646

Source

Official record: FDA (Device enforcement) ↗

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