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Discovery recallZ-1054-2023 · Ge Medical Systems Israel, Functional Imaging · initiated Dec 19, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Ge Medical Systems Israel, Functional Imaging or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

GE Healthcare issue an URGENT MEDICAL DEVICE CORRECTION on 12/19/2022 by mail. The notice explained the issue and the risk, and requested the following action by taken: .GE Healthcare asks that you STOP USE of your Nuclear Medicine system, if your system is listed in the Affected Product Details and Appendix of this letter, until an inspection of your system is completed by GE Healthcare and you have been provided with a letter indicating the system can be returned to clinical use. .GE Healthcare will correct all affected products at no cost to you. GE Healthcare will inspect your system to ensure that the appropriate mitigation is correctly implemented to address this potential life-threatening concern. A GE Healthcare representative will contact you to arrange for this correction. .If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Recall details

Recall number
Z-1054-2023
Status
Open, Classified
Initiated by the company
Dec 19, 2022
Posted by the FDA
Feb 8, 2023
Recalling firm
Ge Medical Systems Israel, Functional Imaging
Quantity
748 units
Product code
KPS
FDA submissions
K111445
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.

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

Code information (models, lots, serial numbers)

Show the full code information (18k characters)

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.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

2 devices cleared under K111445 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 91456).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page