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FDA (Device enforcement)Recalled 2024-03-12class ii

Philips North America Llc: Ingenia Elition S, Magnetic Resonance System.

Hazard

Patient support table floor plate may be incorrectly installed.

Details from the source

Reason for recall: Patient support table floor plate may be incorrectly installed. Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Esto Quantity: 131 units Lot/code info: Model No. 781357, 782106; UDI-DI 884838088108, 884838098329; Serial No. 46065, 46071, 46077, 46025, 46224, 46005, 46003, 46001, 46008, 46004, 46007, 46032, 46011, 46012, 46013, 46015, 46016, 46017, 46019, 46021, 46002, 46018, 46020, 46023, 46024, 46046, 46026, 46027, 46029, 46030, 46031, 46033, 46109, 46034, 46036, 46039, 46037, 46052, 46041, 46042, 46045, 46088, 46050, 46048, 46049, 46058, 46053, 46055, 46054, 46061, 46060, 46057, 46014, 46059, 46044, 46067, 46066, 46068, 46069, 46075, 46076, 46078, 46081, 46082, 46084, 46086, 46083, 46085, 46089, 46104, 46094, 46092, 46101, 46093, 46095, 46200, 46201, 46202, 46203, 46204, 46205, 46206, 46107, 46208, 46207, 46209, 46211, 46217, 46213, 46214, 46215, 46218, 46111, 46219, 46220, 46222, 46226, 46258, 46231, 46228, 46233, 46235, 46237, 46239, 46249, 46240, 46241, 46242, 46234, 46243, 46245, 46247, 46119, 46268, 46097, 46282, 46289, 46305, 46304, 46263, 46310, 46121, 46315, 46265, 46269, 46270, 46325, 46324, 46331, 46338, 46352.

UPC codes

884838088108, 884838098329

Source

Official record: FDA (Device enforcement)

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

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