Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;

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

Code information: Model Numbers: (1) 781358, (2) 782107, (3) 782136; UDI-DI: (1) 00884838088115, (2) 00884838098336, (3) 00884838108608; Serial Numbers: (1) 45010, 45023, 45028, 45029, 45032, 45033, 45034, 45037, 45040, 45041, 45043, 45045, 45046, 45048, 45049, 45053, 45066, 45070, 45072, 45076, 45087, 45090, 45091, 45092, 45093, 45102, 45105, 45108, 45115, 45116, 45119, 45127, 45136, 45138, 45140, 45144, 45147, 45154, 45156, 45157, 45162, 45168, 45181, 45184, 45189, 45191, 45194, 45205, 45222, 45227, 45231, 45243, 45244, 45245, 45246, 45250, 45252, 45263, 45272, 45277, 45278, 45289, 45290, 45296, 45317, 45319, 45323, 45328, 45333, 45335, 45340, 45342, 45362, 45374, 45379, 45414, (2) 45503, 45508, 45519, 45523, 45525, 45530, 45532, 45533, 45534, 45536, 45542, 45543, 45545, 45547, 45551, 45559, 45560, 45561, 45568, 45573, 45574, 45578, 45580, 45589, 45594, 62011, 62023, 62024, 62026, 62030, 62031, 62033, 62035, 62038, 62040, 62041, 62047, 62048, 62051, 62052, 62056, 62058, 62059, 62061, 62062, 62065, 62070, 62071, 62073, 62080, 62081, 62082, 62083, 62088, 62092, 62134, 62136, 62137, 62152, 62153, 62159, 62178, 62181, 62182, 62191, 62197, 62198, 62199, 62212, (3) 28500, 28502, 28503, 28504, 28506, 28507, 28509, 28510, 28514, 28515, 28516, 28517, 28518, 28520, 28521, 28523, 28524, 28525, 28526, 28527, 28528, 28529, 28531, 28532, 28533, 28535, 28536, 28537, 28538, 28539, 28540, 28542, 28543, 28545, 28546, 28547, 28548, 28550, 28552, 28554, 28555, 28559, 28560, 28561, 28563, 28564, 28565, 28566, 28568, 28569, 28572, 28575, 28581;

Distribution pattern: 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, Martinique, Mexico, Moldova, Monaco, Netherlands, New Zealand, Norway, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, U.A.E.