FDA Device Recall Z-1054-2023

Device

GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 / Dismount, c) 830 /, d) 830 / 5842894-20, e) 830 / Dismount / 50HZ, f) 830 / Dismount / 60HZ, g) 830 3/8 inch Detector, h) 830 BJ, i) 830 BJ / 5144407, j) 830 BJ / Dismount, k) 830 ES DEM, l) 830 NM Cyber Defense Configuration Gantry 3/8 inch, m) 830 NM Gantry 3/8 inch, n) 830 NM Gantry 5/8 inch, o) 870 DR NM GANTRY FINAL - NEW ROTOR, p) B615 to D630 UPG, q) D630 NM GANTRY, r) D630 NM GANTRY 3/8 inch WITH NEW ROTOR - MEA, s) D630 NM Gantry 3/8 inch, t) D630 NM GANTRY FINAL ASSEMBLY_, u) D630 with new rotor, v) D630 with new rotor/ 5144407 / Dismount, w) D630 with new rotor/ Dismount, x) DISCOVERY D630 X 3/8 inch, y) DISCOVERY D630 X 3/8 inch, z) DISCOVERY D630 X 3/8 inch, aa) DISCOVERY D630 x 3/8 inch BHW, bb) DISCOVERY D630 X 3/8 inch BJG, cc) DISCOVERY D630 X 3/8 inch MEA, dd) DISCOVERY NM 830 3/8 inch, ee) DISCOVERY NM 830 3/8 inch, ff) NM 830 3/8 inch, gg) NM 830 3/8 inch BJ, hh) NM 830 ES, ii) NM DISCOVERY D630 3/8 inch, jj) NUC GOLDSEAL D630 X 3/8 inch. Emission Computed Tomography System

Lot / serial / GTIN: a) 830: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3AG2200003, NT3AG2000015BH, NT3AG2100015BH, NT3AG2200006BH; b) 830 / Dismount: Catalog number To be provided, UDI/DI Not Applicable, Serial numbers: NT3AG2100016BH; c) 830 /: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3AG2100009BH; d) 830 / 5842894-20: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3AG2200013; e) 830 / Dismount / 50HZ: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3AG2000017BH; f) 830 / Dismount / 60HZ: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3AG2100001; g) 830 3/8 inch Detector: Catalog number H3910AC, UDI/DI Not Applicable, Serial Numbers: 830Y60105; h) 830 BJ: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3AG1900009BH; Catalog number 5376204-32-1, UDI/DI Not Applicable, Serial Numbers: NT3AG1900015BH; i) 830 BJ / 5144407: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3AG1900008BH; j) 830 BJ / Dismount: Catalog number 5376204-32-1, UDI/DI To be provided, Serial Numbers: NT3AG1900016BH; k) 830 ES DEM: Catalog number H3910AC, UDI/DI Not Applicable, Serial Numbers: 83EZ88002, 830Z60256; l) 830 NM Cyber Defense Configuration Gantry 3/8 inch: Catalog number H3910AG, UDI/DI Not Applicable, Serial Numbers: 830Z60185, 830Z60224, 830Z60225; m) 830 NM Gantry 3/8 inch: Catalog number H3910AC, UDI/DI Not Applicable, Serial Numbers: 830Y60050, 830Z60199, 830A60284, 830A60290, 830X60001, 830X60004, 830Y60056, 830Y60069, 830Z60158, 830Z60182, 83EA88010, 830Z60183, 830A60282, 830Z60192, 830A60271, 830Y60122, 830A60298, 830A60289, 830Y60048, 830Y60036, 830Z60239, 830A60294, 830Y60046, 830X60012, 830Y60054, 830Z60269, 830X60018, 830A60283, 830Y60089, 830Y60096, 830Z60165, 830Z60169, 830Y60051, 830Z60244, 830A60288, 830X60026, 830Y60030, 830Z60197, 830Z60227, 830A60277, 830A60334, 830Y60079, 830Y60131, 830Y60141, 83EA88008, 830Z60238, 830Z60207, 830Z60248, 830Y60137, 830Z60149, 830Z60175, 830Y60076, 830Y60092, 830Y60090, 830A60301, 830A60279, 830Z60178, 830Z60153, 830Y60132, 830X60011, 830X60016, 830Y60102, 830Z60253, 830Z60264, 830Y60049, 830Z60265, 830Z60254, 830Y60081, 830Z60263, 830Z60200, 830A60308, 830A60300, 830Z60171, 830Y60057, 830Y60029, 830Y60106, 830Y60059, 830Z60177, 830A60291, 830Z60267, 830Z60174, 830Z60245, 830Y60074, 830Z60167, 830Y60071, 830Z60246, 830Z60223, 830Z60201, 830Y60045, 830X60019, 83EZ88001, 830Y60124, 830A60306, 830A60297, 830Z60213, 830Y60111, 830Y60127, 830Y60094, 830Z60258, 830Y60058, 830Z60218, 830Y60138, 830A60280, 830A60274, 830Z60211, 830Y60101, 830Z60210, 830Z60260, 830Z60234, 830Y60118, 830X60027, 830Z60228, 830Z60168, 830Z60214, 830Y60044, 830Y60053, 830Z60173, 830Z60195, 830Y60123, 830Y60117, 830Y60129, 830Z60148, 830X60023, 830X60006, 830Y60104, 830X60015, 830Y60121, 830A60281, 830Y60133, 830Y60098, 830Z60268, 830Z60194, 830Z60198, 830X60014, 830Y60040, 830X60003, 830Z60159, 830Z60237, 830Y60060, 830A60278, 83EA88006, 830Z60222, 830Z60250, 830Z60181, 830Y60134, 830Z60152, 830Z60202, 830Z60220, 830Z60230, 830Y60062, 830Y60097, 830Z60176, 830Z60196, 830Y60125, 830X60025, 830A60293, 830A60307, 830Z60249, 830Z60180, 830Y60064, 830Y60078, 830Y60115, 830Y60114, 830Y60043, 830Y60108, 830A60275, 830Y60130, 830Z60229, 830A60292, 830Z60163, 830Y60128, 830X60021, 830Z60266, 830Y60100, 830A60304, 830Y60099, 830Y60034, 830Y60087, 830X60028, 830Y60084, 830Y60055, 830Y60136, 830Z60188, 830Z60206, 830Z60151, 830X60017, 830Y60140, 83EA88009, 830Z60154, 830Y60112, 830A60276, 830Y60082, 830Y60093, 830A60305, 830Z60232, 830Y60066, 830Z60191, 830Z60236, 830A60285, 830Z60235, 830Z60157, 830Y60126, 830Y60142, 830Y60035, 83EA88007, 830A60286, 830Y60107, 830Y60080, 830X60002, 830Z60270, 830Y60067, 830Z60193, 830Z60172, 830X60022, 830Y60095, 830Y60119, 830Y60042, 830Z60156, 830X60024, 830B60457, 830Y60047, 830Z60205, 830X60013, 830Y60073, 830Y60032, 830A60310, 830Z60219, NT3AG1900017BH, 830Z60257, 830Z60247, 830Z60240, 830Z60203, 830Y60085, 830Y60077, 830Z60255, 830A60311, 830Y60033, 830X60020, 830A60287, 830Y60038, 83EZ88004, 83EZ88005, 830X60010, 830Z60252, 830Z60166, 830Y60061, 830Y60091, 830Z60184, 830A60309, 830Z60217, 830Z60155, 830X60005, 830X60008, 830X60009, 830Y60052, 830Y60063, 830Y60143, 830Y60144, 830Y60146, 830Z60231, 830Z60187, 830A60296, 830Y60041, 830Y60088, 830Z60226, 830Z60262, 830X60007, 830Z60259, 830Z60212, 830Y60065, 830Y60135, 830Z60204, 830Y60072, 830Z60160; UDI/DI UDI_Not_Required_2, Serial Numbers: 830Y60113; , UDI/DI UDI_Not_Required_6, Serial Numbers: 830A60299; UDI/DI 010084068214082921830A6032811210700, Serial Numbers: 830A60328; UDI/DI 010084068214082921830Z6015011200100, Serial Numbers: 830Z60150; UDI/DI 010084068214082921830A6027211210100, Serial Numbers: 830A60272; UDI/DI 010084068214082921830B6042411220500, Serial Numbers: 830B60424; UDI/DI 010084068214082921830Z6019011200400, Serial Numbers: 830Z60190; UDI/DI 010084068214082921830A6027311210100, Serial Numbers: 830A60273; UDI/DI 010084068214082921830Z6018911200400, Serial Numbers: 830Z60189; UDI/DI 010084068214082921830Y6007511190600, Serial Numbers: 830Y60075; UDI/DI (01)00840682140829(21)830B60400(11)220200, Serial Numbers: 830B60400; UDI/DI 010084068214082921830Z6017011200200, Serial Numbers: 830Z60170; UDI/DI (01)00840682140829(21)830A60346(11)211100, Serial Numbers: 830A60346; UDI/DI 010084068214082921830Y6010311190900, Serial Numbers: 830Y60103; UDI/DI 010084068214082921830Y6014511191200, Serial Numbers: 830Y60145; UDI/DI 010084068214082921830A6030311210500, Serial Numbers: 830A60303; UDI/DI (01)00840682140829(21)830A60345(11)211000, Serial Numbers: 830A60345; UDI/DI 010084068214082921830A6029511210300, Serial Numbers: 830A60295; UDI/DI 010084068214082921830Z6023311200900, Serial Numbers: 830Z60233; UDI/DI 010084068214082921830Z6020911200600, Serial Numbers: 830Z60209; UDI/DI (01)00840682140829(21)830B60386(11)220100, Serial Numbers: 830B60386; UDI/DI (01)00840682140829(21)830B60434(11)220600, Serial Numbers: 830B60434; UDI/DI 010084068214082921830Y6010911191000, Serial Numbers: 830Y60109; UDI/DI 010084068214082921830Z6016211200200, Serial Numbers: 830Z60162; UDI/DI 010084068214082921830Z6017911200300, Serial Numbers: 830Z60179; UDI/DI 010084068214082921830Z6018611200300, Serial Numbers: 830Z60186; UDI/DI 010084068214082921830B6042711220500, Serial Numbers: 830B60427; UDI/DI 010084068214082921830A6037811211200, Serial Numbers: 830A60378; , UDI/DI To be provided, Serial Numbers: 830B60383, 830A60337, 830A60373, 830A60368, 830B60387, 830B60458, 830B60459, 830B60460, 830B60462, 830B60464, 830B60465, 830B60466, 830B60421, 830B60430, 830B60443, 830B60456, 830B60473, 830B60384, 83EB88026, 83EA88017, 830A60317, 830B60401, 830B60432, 830B60422, 830B60467, 830B60471, 830B60398, 830A60364, 83EB88027, 83EB88028, 830A60326, 830B60411, 830B60469, 830B60472, 830B60389, 830A60333, 830A60347, 830A60348, 830B60447, 830A60313, 830A60375, 830A60374, 830B60412, 830A60339, 830B60461, 830B60463, 830B60470, 830A60365, 830B60446, 830B60397, 83EB88034, 83EB88025, 83EA88011, 830B60431, 830B60428, 830B60416, 830B60441, 830A60363; n) 830 NM Gantry 5/8 inch: Catalog number H3910AD, UDI/DI To be provided, Serial Numbers: 830B60468, 830B60379; o) 870 DR NM GANTRY FINAL - NEW ROTOR: Catalog number 5376204-32-1, UDI/DI Not Applicable, Serial Numbers: NT3AG2000009BH; p) B615 to D630 UPG: Catalog number To be provided, UDI/DI To be provided, Serial Numbers: NT2UG2100001; Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT2UG2100002; q) D630 NM GANTRY: Catalog number H3100JY, UDI/DI 01008406821392742163GX5002611180700, Serial Numbers: 63GX50026; Catalog number H3100JY, UDI/DI Not Applicable, Serial Numbers: 0000063GX50023; r) D630 NM GANTRY 3/8 inch WITH NEW ROTOR - MEA: Catalog number 5376204-31-1, UDI/DI To be provided, Serial Numbers: NT2PG2000001BH; s) D630 NM Gantry 3/8 inch: Catalog number H3101RH, UDI/DI Not Applicable, Serial Numbers: 63GY50074, 63GX50024, 63GZ50134, 63GY50110, 63GY50119, 63GY50067, 63GY50123, 63GX50001, 63GX50037, 63GX50060, 63GY50089, 63GY50087, 63GY50098, 63GY50097, 63GX50034, 63GZ50152, 63GY50094, 63GY50128, 63GY50131, 63GX50014, 63GY50079, 63GY50130, 63GY50101, 63GZ50147, 63GZ50136, 63GX50019, 63GZ50150, 63GZ50141, 63GY50078, 63GX50022, 63GX50021, 63GX50031, 63GX50018, 63GY50082, 63GX50009, 63GY50080, 63GY50118, 63GZ50133, 63GY50077, 63GX50043, 63GY50116, 63GX50020, 63GX50054, 63GX50008, 63GX50035, 63GX50050, 63GX50061, 63GX50062, 63GY50085, 63GZ50151, 63GY50125, 63GY50102, 63GX50032, 63GX50055, 63GY50090, 63GX50013, 63GX50047, 63GX50002, 63GX50025, 63GX50033, 63GX50038, 63GY50115, 63GX50044, 63GY50129, 63GY50120, 63GY50068, 63GX50063, 63GY50104, 63GY50069, 63GX50016, 63GY50075, 63GX50017, 63GX50005, 63GY50084, 63GX50029, 63GZ50135, 63GX50012, 63GY50127, 63GY50124, 63GX50046, 63GZ50148, 63GX50039, 63GX50049, 63GY50083, 63GX50011, 63GX50030, 63GY50108, 63GY50103, 63GY50113, 63GY50114, 63GZ50146, 63GX50057, 63GZ50145, 63GA50153, 63GZ50149, 63GY50100, 63GZ50142, 63GX50045, 63GA50155, 63GA50154, 63GY50111, 63GY50112, 0000063GX50048, 63GX50040, 63GX50003, 63GX50065, 63GZ50137, 63GY50107, 63GZ50138, 63GX50042, 63GY50088, 63GY50126, 63GX50053, 63GX50004, 63GY50086, 63GZ50132, 63GX50056, 63GX50066, 63GX50059;UDI/DI 01008406821392742163GY5007611190200, Serial Numbers: 63GY50076; UDI/DI 01008406821392742163GX5005111181000, Serial Numbers: 63GX50051; UDI/DI 01008406821392742163GX5005211181000, Serial Numbers: 63GX50052; UDI/DI 01008406821392742163GY5007011190100, Serial Numbers: 63GY50070; UDI/DI 01008406821392742163GY5009511190400, Serial Numbers: 63GY50095; UDI/DI 01008406821392742163GY5012111191100, Serial Numbers: 63GY50121; UDI/DI 01008406821392742163GX5002711180700, Serial Numbers: 63GX50027; UDI/DI 01008406821392742163GX5003611180700, Serial Numbers: 0000063GX50036; UDI/DI 01008406821392742163GY5009611190400, Serial Numbers: 63GY50096; UDI/DI 01008406821392742163GX5000711180500, Serial Numbers: 63GX50007; UDI/DI 01008406821392742163GX5000611180500, Serial Numbers: 63GX50006; UDI/DI 01008406821392742163GX5001011180600, Serial Numbers: 63GX50010; UDI/DI 01008406821392742163GX5001511180600, Serial Numbers: 63GX50015; UDI/DI 01008406821392742163GY5011711190900, Serial Numbers: 63GY50117; UDI/DI 01008406821392742163GY5007111190100, Serial Numbers: 63GY50071; UDI/DI 01008406821392742163GY5007211190100, Serial Numbers: 63GY50072; UDI/DI (01)00840682139274(21)63GY50106(11)190700, Serial Numbers: 63GY50106; UDI/DI 01008406821392742163GY5007311190100, Serial Numbers: 63GY50073; UDI/DI To be provided, Serial Numbers: 63GX50041, 63GY50105, 63GA50161, 63GB50165, 63GA50162, 63GA50157, 63GA50159, 63GA50160, 63GA50156, 63GA50163, 63GB50166; t) D630 NM GANTRY FINAL ASSEMBLY, : Catalog number 5791570, UDI/DI To be provided, Serial Numbers: 830B60423, 830B60429; u) D630 with new rotor: Catalog number H2405AC, UDI/DI To be provided, Serial Numbers: NT2PG1900006, NT2PG1900005; v) D630 with new rotor/ 5144407 / Dismount: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT2PG1900007BH; w) D630 with new rotor/ Dismount: Catalog number 5376204-31-1, UDI/DI Not Applicable, Serial Numbers: NT2PG1800001BH; x) DISCOVERY D630 X3/8 inch: Catalog number 5376204-31-1, UDI/DI Not Applicable, Serial Numbers: NT2PG1900009BH, NT2PG1900008BH; y) DISCOVERY D630X 3/8 inch: Catalog number 5791570, UDI/DI Not Applicable, Serial Numbers: 0000063GZ50139; z) DISCOVERY D630X3/8 inch: Catalog number H3101RH, UDI/DI 01008406821392742163GY5009111190400, Serial Numbers: 63GY50091; UDI/DI Not Applicable, Serial Numbers: 63GY50093, 63GY50099, 63GZ50144, 63GZ50140, 63GY50122, 63GY50092, 63GB50164, 63GX50064, 63GX50028, 63GX50058, 63GY50081, 63GY50109, 63GZ50143; aa) DISCOVERY D630x3/8 inch BHW: Catalog number H2405AC, UDI/DI 01008406821393281119060021NT2PG1900010BH, Serial Numbers: NT2PG1900010BH; bb) DISCOVERY D630X3/8 inch BJG: Catalog number 5376204-31-1, UDI/DI Not Applicable, Serial Numbers: NT2PG1900004BH, NT2PG1900001BH, NT2PG1900002BH, NT2PG1900012BH; cc) DISCOVERY D630X3/8 inch MEA: Catalog number 5376204-31-1, UDI/DI 01008406821393281119100021NT2PG1900011BH, Serial Numbers: NT2PG1900011BH; dd) DISCOVERY NM 830 3/8 inch: Catalog number 5376204-32-1, UDI/DI Not Applicable, Serial Numbers: NT3AG2200012BH; UDI/DI To be provided, Serial Numbers: NT3AG2100004BH, NT3AG2200007BH; UDI/DI Not Applicable, Serial Numbers: NT3AG2200012BH; ee) DISCOVERY NM 830 3/8 inch: Catalog number H3910AC, UDI/DI Not Applicable, Serial Numbers: 830Y60110, 830Z60164; ff) NM 830 3/8 inch: Catalog number 5791570, UDI/DI To be provided, Serial Numbers: 830A60336, 830Y60031; Catalog number 5376204-31-1, UDI/DI To be provided, Serial Numbers: NT3AG2000005BH; Catalog number 5376204-32, UDI/DI 010084068214082921830A6035511211100, Serial Numbers: 830A60355; UDI/DI 010084068214082921830A6032511210700, Serial Numbers: 830A60325; UDI/DI 010084068214082921830A6037111211200, Serial Numbers: 830A60371; UDI/DI 010084068214082921830B6040911220300, Serial Numbers: 830B60409; UDI/DI 010084068214082921830B6043911220700, Serial Numbers: 830B60439; UDI/DI 010084068214082921830B6041411220400, Serial Numbers: 830B60414; UDI/DI 010084068214082921830A6032411210700, Serial Numbers: 830A60324; UDI/DI 010084068214082921830B6041511220400, Serial Numbers: 830B60415; UDI/DI 010084068214082921830B6043311220600, Serial Numbers: 830B60433; UDI/DI 010084068214082921830A6032911210800, Serial Numbers: 830A60329; UDI/DI 010084068214082921830B6044211220700, Serial Numbers: 830B60442; UDI/DI 01008406821408292183EB8803111220700, Serial Numbers: 83EB88031; UDI/DI 010084068214082921830B6044411220700, Serial Numbers: 830B60444; UDI/DI 010084068214082921830A6034411211000, Serial Numbers: 830A60344; UDI/DI 010084068214082921830B6040411220300, Serial Numbers: 830B60404; UDI/DI 010084068214082921830A6033211210800, Serial Numbers: 830A60332; UDI/DI 010084068214082921830A6032311210700, Serial Numbers: 830A60323; UDI/DI 010084068214082921830B6040211220200, Serial Numbers: 830B60402; UDI/DI 010084068214082921830A6035211211100, Serial Numbers: 830A60352; UDI/DI 010084068214082921830B6044811221000, Serial Numbers: 830B60448; UDI/DI 010084068214082921830A6031511210600, Serial Numbers: 830A60315; UDI/DI 010084068214082921830A6031811210600, Serial Numbers: 830A60318; UDI/DI 010084068214082921830B6042511220500, Serial Numbers: 830B60425; UDI/DI 010084068214082921830A6031911210600, Serial Numbers: 830A60319; UDI/DI 010084068214082921830A6036611211200, Serial Numbers: 830A60366; Catalog number H3910AC, UDI/DI Not Applicable, Serial Numbers: 830Y60147, 830B60455, 830Z60261, 830Z60221, 830Z60215, 830Y60070, 830Y60083, 830Y60037, 830Z60161, 830Y60039, 830A60302, 830Z60216, 830Z60242, 830Z60241, 830Z60251, 830Y60086, 830Z60243, 830Z60208; UDI/DI UDI_Not_Required_2, Serial Numbers: 830Y60116; UDI/DI To be provided, Serial Numbers: 830A60356, 830B60449, 830A60350, 83EB88032, 830A60322, 830B60445, 830B60435, 830A60358, 830B60408, 830A60349, 830B60453, 830A60357, 830A60335, 830B60410, 830B60395, 830A60354, 830B60385, 830A60331, 830B60396, 830A60360, 830B60381, 830B60406, 830B60403, 830A60320, 830A60321, 830B60426, 830B60388, 830A60369, 830B60399, 830B60419, 830A60377, 830A60316, 830B60382, 830B60452, 830A60370, 830A60376, 830B60413, 830A60314, 830A60367, 830B60394, 830B60436, 830A60342, 830A60362, 830B60440, 830B60407, 830A60312, 830B60380, 830B60418, 830A60353, 830A60330, 830B60390, 830A60372, 830A60359, 830A60341, 830A60338, 830A60327, 830B60405, 830A60361, 830B60454, 830A60340, 830A60351; Catalog number To be provided, UDI/DI To be provided, Serial Numbers: 830B60437, 830B60393, 830B60420, 830B60438, 830A60343; gg) NM 830 3/8 inch BJ: Catalog number 5376204-32-1, UDI/DI Not Applicable, Serial Numbers: NT3AG2200001BH, NT3AG2100007BH, NT3AG2100003BH, NT3AG2000008BH, NT3AG2000002BH, NT3AG2200010BH, NT3AG1900002BH , NT3AG2200009BH, NT3AG1900014BH, NT3AG1900012BH, NT3AG2000006BH, NT3AG2100008BH, NT3AG2000013BH, NT3AG2100010BH, NT3AG2200005BH, NT3AG1900011BH, NT3AG2000016BH, NT3AG2100002BH, NT3AG2200011BH, NT3AG2100011BH, NT3AG1900018BH, NT3AG2000001BH, NT3AG1900003BH, NT3AG1900001BH, NT3AG1800001BH, NT3AG2100014BH, NT3AG1900010BH, NT3AG2000003BH, NT3AG2000012BH, NT3AG1900006BH, NT3AG2100005BH, NT3AG2000011BH, NT3AG2200008BH, NT3AG1800002BH, NT3AG2000010BH; UDI/DI To be provided, Serial Numbers: NT3AG2200014BH, NT3AG1900013BH, NT3AG2200002BH, NT3AG2100012BH, NT3AG2100013BH; Catalog number H2406AA, UDI/DI Not Applicable, Serial Numbers: NT3DG1800003BH, NT3AG1900004BH, NT3AG2200016, NT3AG2200015BH; Catalog number H3910AC, UDI/DI Not Applicable, Serial Numbers: 83EZ88003; Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3AG2200004BH; Catalog number To be provided, UDI/DI To be provided, Serial Numbers: NT3AG1900005BH, NT3AG2000004BH; hh) NM 830 ES: Catalog number 5376204-32, UDI/DI 01008406821408292183EA8801811211000, Serial Numbers: 83EA88018; UDI/DI 01008406821408292183EA8801411210800, Serial Numbers: 83EA88014; UDI/DI 01008406821408292183EB8801911220100, Serial Numbers: 83EB88019; UDI/DI 01008406821408292183EB8802311220200, Serial Numbers: 83EB88023; UDI/DI 01008406821408292183EB8803011220500, Serial Numbers: 83EB88030; UDI/DI 01008406821408292183EA8801211210600, Serial Numbers: 83EA88012; UDI/DI 01008406821408292183EA8801511210900, Serial Numbers: 83EA88015; UDI/DI 01008406821408292183EA8801311210800, Serial Numbers: 83EA88013; UDI/DI 01008406821408292183EB8802411220200, Serial Numbers: 83EB88024; Catalog number H3910AC, UDI/DI To be provided, Serial Numbers: 83EB88029, 83EB88022, 83EA88016; UDI/DI Not Applicable, Serial Numbers: 83EB88021; Catalog number To be provided, UDI/DI To be provided, Serial Numbers: 83EB88020; ii) NM DISCOVERY D630 3/8 inch: Catalog number 5474054, UDI/DI To be provided, Serial Numbers: 22404; jj) NUC GOLDSEAL D630X3/8 inch: Catalog number S9630NU, UDI/DI Not Applicable, Serial Numbers: NT2QG1900003BH.

Quantity: 748 units

Reason for recall

A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.

Recall record

Recall number

Z-1054-2023

Classification

Class I

Status

Ongoing

Voluntary or mandated

Voluntary: Firm initiated

Firm notification

Letter

Distribution

Worldwide distribution. US nationwide including Puerto Rico, Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, El Salvador, Ethiopia, Finland, France, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Libya, Lithuania, Malaysia, Martinique, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uzbekistan, and Vietnam.

Recall initiated

2022-12-19

Classified by FDA Center

2023-02-08

FDA published

2023-02-15

Recalling firm

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING