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Philips North America Llc Recall 94233

Description: Intera 1.5T, Magnetic Resonance System.

Philips North America Llc Recall 94233 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1575-2024
Event ID94233
Event DescriptionIntera 1.5T, Magnetic Resonance System.
Product TypeDevices
DistributionWorldwide 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, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.
Quantity347 units
Recall ReasonPatient support table floor plate may be incorrectly installed.
Device Classification20240424
Device Code InfoModel No. 781195, 781295; UDI-DI n/a; Serial No. 30030, 18972, 18784, 18616, 18668, 18901, 30047, 18868, 18822, 18974, 18607, 18864, 18861, 18966, 18566, 18586, 18580, 18618, 18664, 18612, 18734, 18611, 18647, 18637, 30029, 18681, 18504, 18694, 18501, 18527, 18646, 18719, 18680, 18705, 18639, 18716, 18748, 18743, 18727, 18752, 18675, 18759, 18768, 18796, 18805, 18772, 18813, 18794, 18798, 18854, 18766, 18873, 18535, 18544, 18557, 18698, 18711, 18730, 18765, 18773, 18774, 18781, 18820, 18870, 18877, 18886, 18885, 18536, 18856, 18888, 18908, 18890, 18871, 18887, 18907, 18917, 18897, 18923, 18899, 18914, 18931, 18895, 18898, 18941, 18944, 18946, 18905, 18927, 18916, 18952, 18953, 18967, 18833, 18896, 18964, 18958, 18980, 18984, 18987, 18971, 18977, 18949, 18962, 18991, 18997, 20409, 18989, 20412, 20402, 18999, 20414, 18919, 20415, 20426, 20427, 20429, 18976, 20431, 18951, 18937, 30038, 30036, 30053, 30043, 30061, 30058, 30064, 18982, 18981, 30065, 20439, 30062, 30055, 30035, 30075, 30083, 30070, 20424, 30101, 30052, 30107, 20441, 30100, 30104, 30105, 30109, 30102, 30106, 30099, 30113, 30114, 30115, 30116, 30120, 30122, 30123, 30125, 30128, 30130, 30134, 30133, 30142, 30137, 30140, 30143, 30131, 30119, 30135, 30145, 30148, 18842, 18654, 18995, 30051, 30084, 30149, 30095, 30118, 30152, 30154, 30153, 30155, 30138, 30158, 30159, 30160, 30162, 30028, 30163, 30164, 30169, 30167, 30168, 30171, 30173, 30174, 18763, 30175, 30176, 30177, 30178, 30179, 30180, 30182, 30181, 30183, 30184, 30185, 30188, 30186, 30187, 30190, 30189, 30191, 30192, 30196, 30170, 30198, 30203, 30206, 30208, 30213, 30214, 30215, 30216, 30217, 30218, 30219, 30220, 30221, 30209, 30222, 30197, 30223, 30226, 30227, 30201, 30228, 30230, 30231, 30232, 30233, 30234, 30235, 30237, 30240, 30241, 30242, 18516, 30243, 30244, 18939, 30245, 30246, 30250, 30248, 30249, 30251, 30252, 30253, 30254, 30256, 30259, 30263, 30262, 30264, 18593, 30261, 30270, 30266, 30267, 30268, 30269, 30272, 30276, 30277, 30279, 30281, 30283, 30284, 30285, 30287, 18569, 30207, 30288, 30289, 30290, 30291, 30294, 30210, 30199, 30200, 30280, 30265, 30297, 30298, 30304, 30293, 30307, 30308, 30282, 30306, 30309, 30310, 30311, 18517, 18708, 18554, 30314, 30315, 30059, 18579, 18546, 30017, 18876, 18539, 30302, 18628, 18725, 18749, 18660, 18723, 18669, 18678, 18542, 18674, 18738, 18534, 18667, 30098, 18973, 18904, 30063, 18657, 20400, 30091, 18932, 18740, 18850, 18875, 18920, 30094, 18755, 18947, 18659, 18538, 18739.
Center Classification Date20240417
Recall Initiation Date20240312
Recalling FirmPhilips North America Llc
Initial Notification Letter
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