Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2. 782106(S), 3. 782137(S), 4. 781358(X), 5. 782107(X), 6. 782119(X), 7. 782136(X), 8. 782158(X);
Check against the official notice below — it lists the full affected range.
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Reason for recall: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory. Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salva Quantity: 596 Lot/code info: 1. Model Numbers (REF): 781357(S); UDI-DI: 884838088108; Serial Numbers: 46083, 46045, 46095, 46119, 46121, 46024, 46044, 46055, 46061, 46052, 46001, 46005, 46011, 46048, 46057, 46060, 46066, 46078, 46081, 46016, 46026, 46032, 46033, 46037, 46046, 46054, 46058, 46059, 46068, 46069, 46075, 46082, 46003, 46019, 46111, 46007, 46107, 46067, 46093, 46030, 46031, 46049, 46050, 46089, 46014, 46065, 46071, 46077, 46088, 46109; 2. Model Numbers (REF): 782106(S); UDI-DI: 884838098329; Serial Numbers: 46247, 46250, 46316, 46376, 46200, 46368, 46324, 46331, 46338, 46363, 46367, 46383, 46394, 46398, 46399, 46400, 46201, 46202, 46220, 46225, 46352, 46310, 46234, 46205, 46207, 46209, 46211, 46214, 46215, 46226, 46228, 46235, 46237, 46239, 46240, 46241, 46282, 46281, 46297, 46304, 46317, 46354, 46212, 61010, 46206, 46362, 46393, 46348, 46217, 46289, 46233, 46353, 46213, 46218, 46222, 46384, 46224, 46265, 46286, 46390, 46263, 46307, 46387, 46403; 3. Model Numbers (REF): 782137(S); UDI-DI: 884838108615; Serial Numbers: 64004, 64008, 64024, 64028, 64031, 64046, 64047, 64002, 64003, 64009, 64013, 64034, 64045, 64050, 64030, 64029, 64049, 64051; 4. Model Numbers (REF): 781358(X); UDI-DI: 884838088115; Serial Numbers: 45107, 45142, 45145, 45216, 45241, 45284, 45121, 45257, 45154, 45193, 45253, 45106, 45131, 45259, 45298, 45300, 45302, 45313, 45330, 45344, 45345, 45349, 45352, 45359, 45360, 45363, 45367, 45368, 45370, 45371, 45372, 45377, 45378, 45381, 45390, 45391, 45394, 45396, 45397, 45409, 4541
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.