GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 / Dismount, c) 830 /...
FDA Device Recall #Z-1054-2023 - Class I, December 19, 2022
Recall Summary
| Recall Number | Z-1054-2023 |
| Classification | Class I - Serious risk |
| Date Initiated | December 19, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Location | Tirat Carmel |
| Product Type | Devices |
| Quantity | 748 units |
Product Description
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
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.
Distribution Pattern
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.
Lot / Code Information
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.
Other Recalls from GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1112-2026 | Class II | GE Healthcare Omni Legend, sold under the follo... | Dec 24, 2025 |
| Z-1046-2026 | Class II | SMV BodyTrack, System, Tomography, Computed... | Dec 10, 2025 |
| Z-1047-2026 | Class II | MAXXUS, System, Tomography, Computed, Emission | Dec 10, 2025 |
| Z-1044-2026 | Class II | SMV DSX New Line, System, Tomography, Compu... | Dec 10, 2025 |
| Z-1045-2026 | Class II | SMV DSI, System, Tomography, Computed, Emis... | Dec 10, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.