GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c) 850 3/8...
FDA Recall #Z-1058-2023 — Class I — December 19, 2022
Product Description
GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c) 850 3/8 inch NM Gantry, d) 860 / Dismount, e) 860 3/8 inch NM Gantry, f) 860 5/8 inch NM Gantry, g) 860 BJ, h) NM 830 3/8 inch BJ, i) NM/CT 850 3/8 inch BJ, j) NM/CT 850 3/8 inch ROW, k) NM/CT 850 3/8 inch ROW_, l) NM/CT 850 CT 850 3/8 inch, m) NM/CT 850 ES 3/8 inch, n) NM/CT 850 ES 3/8 inch ROW, o) NM/CT 860 3/8 inch, p) NM/CT 860 3/8 inch BJ, q) NM/CT 860 3/8 inch ROW, r) NM/CT 860 ADVANCE, s) NM/CT 860 advance 3/8 inch NM Gantry, t) NM/CT 860 BEYOND, u) NM/CT 860 beyond 3/8 inch NM Gantry, v) NM/CT 860 China for China, w) NM/CT 860 CT 860 3/8 inch, x) NM/CT 860 ES 3/8 inch, y) NM/CT 860 ES 3/8 inch ROW, z) NM/CT 850 3/8 inch, aa) NM/CT 850 ES 3/8 inch ROW, bb) NM/CT 860 3/8 inch CH, cc) XELERIS 4 DR WORKSTATION; 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.
Recalling Firm
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — Tirat Carmel
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
380 units
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.
Code Information
a) 850: Catalog number 5376204-50-1, UDI/DI Not Applicable, Serial Numbers: NT3BG2200006BH; b) 850 / Dismount: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3BG2100003BH; c) 850 3/8 inch NM Gantry: Catalog number H3907AD, UDI/DI Not Applicable, Serial Numbers: 85EY67037, 850Z61033, 85EY67039, 85EY67048, 850Y61018, 850Y61009, 85EY67035, 85EX67001, 85EX67020, 85EY67045, 85EX67023, 85EY67032, 85EY67046, 850A61063, 850Z61047, 85EY67047, 850Z61053, 850Y61006, 850Y61010, 850X61005, 850Y61021, 85EZ67062, 85EX67019, 85EX67021, 85EA67063, 850A61069, 85EX67008, 85EY67040, 850Z61051, 850Z61038, 850A61075, 850Y61025, 850Z61030, 85EY67015, 85EX67017, 85EY67043, 850Z61042, 850Z61061, 85EY67026, 850A61065, 85EX67012, 850Y61023, 85EY67041, 850A61062, 850A61076, 850Y61012, 850A61064, 85EZ67058, 85EX67006, 850Z61043, 850Z61055, 85EY67042, 85EZ67055, 85EY67036, 85EX67024, 85EY67038, 85EX67022, 85EY67025, 85EZ67060, 850Z61058, 850Z61044, 850Z61045, 850Y61020, 850Z61032, 85EZ67056, 85EA67065, 85EY67028, 850Z61041, 85EX67002, 85EX67009, 850A61072, 850Z61036, 850A61068, 850A61071, 850Z61060, 850Z61034, 850Z61039, 850Z61035, 850Z61040, 85EY67031, 850Z61056, 850Z61057, 850Y61016, 85EX67016, 85EA67066, 85EX67004, 850Z61029, 850Z61031, 85EX67011, 85EX67010, 850Y61013, 850Y61015, 850Y61017, 850A61070, 85EX67005, 850A61073, 85EX67018, 85EY67033, 850Z61027, 85EX67013, 850Z61054, 850X61001, 85EZ67053, 85EZ67054, 85EZ67057, 850X61004, 850Z61059, 850Z61052, 850Y61014, 850Z61048, 850Y61026, 850Y61019, 85EY67044, 850Z61037, 850X61002, 85EX67003, 85EX67014, 850Y61007, 85EY67049, 85EZ67052, 850A61067, 850A61074, 85EY67050, 85EZ67051, 85EY67027; UDI/DI (01)00840682140775(21)850B61120(11)220700, Serial Numbers: 850B61120; UDI/DI 010084068214077521850Y6101111190300, Serial Numbers: 850Y61011; UDI/DI To be provided, Serial Numbers: 850A61083, 85EA67080, 850B61127, 850B61128, 850B61129, 850B61130, 85EB67087, 850B61133, 850B61134, 850B61135, 850B61101, 85EA67070, 850B61119, 850B61102, 850B61115, 85EA67076, CHBB65669, 850B61122, 850B61132, 850B61131, 85EA67075, 85EA67077, 85EB67088, 850A61093, 85EB67086, 850B61126, 850A61089, 85EA67078, 850B61112, 850B61111, 850B61110, 850B61107, 850B61109; Catalog number To be provided, UDI/DI To be provided, Serial Numbers: 60B62111; d) 860 / Dismount: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3CG2100006BH; e) 860 3/8 inch NM Gantry: Catalog number H3908AD, UDI/DI Not Applicable, Serial Numbers: 860Y62009, 860Y62010, 860Z62027, 860Y62005, 860A62049, 860Y62019, 860Y62014, 860Y62025, 860Z62028, 860Y62024, 860Z62038, 860A62063, 860Z62042, 860Y62017, 860A62065, 860A62058, 860Z62046, 860A62057, 860Z62041, 86EA76004, 860B62118, 860Z62043, 860A62060, 860Z62026, 860Y62006, 860Y62015, 860Y62004, 860Z62047, 860Y62020, 860A62050, 860Z62030, 860Y62007, 860X62002, 860Z62032, 860Y62021, 86EA76003, 860Z62040, 860Z62037, 860Z62031, 860A62062; , UDI/DI 010084068214075121860A6207711211000, Serial Numbers: 860A62077; UDI/DI (01)00840682140751(21)860B62097(11)220300, Serial Numbers: 860B62097; UDI/DI 010084068214075121860B6209611220300, Serial Numbers: 860B62096; UDI/DI 010084068214075121860A6205911210400, Serial Numbers: 860A62059; UDI/DI 010084068214075121860A6206811210600, Serial Numbers: 860A62068; UDI/DI 010084068214075121860Y6202311191100, Serial Numbers: 860Y62023; UDI/DI 010084068214075121860Y6201311190600, Serial Numbers: 860Y62013; UDI/DI To be provided, Serial Numbers: 860A62067, 860Y62016, 860B62117, 860B62100, 860B62105, 860B62090, 860A62072, 860B62108, 860B62110, 860A62078, 860A62083, 860B62094, 860A62066, 860A62084, 860A62071, 860A62070, 860A62073, 860A62069, 860B62095, 860A62086, 860A62081, 860A62085, 860B62099, 860B62115, 860A62082, 860B62114, 860A62074, 860Z62034, 86EB76006, 860B62122, 860B62119, 860B62121, 860B62089, 86EB76007, 860A62076, 860A62079, 860B62116, 86EB76009, 860B62120, 860B62093, 860A62080, 860B62098, 860B62091, 860B62103; f) 860 5/8 inch NM Gantry: Catalog number H3908AE, UDI/DI To be provided, Serial Numbers: 860X62001; , UDI/DI Not Applicable, Serial Numbers: 860Z62035; g) 860 BJ: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3CG1900007BH, NT3CG1900008BH, NT3CG1900009BH; h) NM 830 3/8 inch BJ: Catalog number 5376204-50-1, UDI/DI To be provided, Serial Numbers: NT3AG1900007BH, NT3AG2100001BH, NT3AG2100006BH; i) NM/CT 850 3/8 inch BJ: Catalog number 5376204-50-1, UDI/DI Not Applicable, Serial Numbers: NT3BG2000003BH, NT3BG2100001BH, NT3BG2200001BH, NT3BG1900001BH, NT3BG2200002BH, NT3BG2000004BH, NT3BG2100004BH, NT3BG2200005BH; : Catalog number H2407AA, UDI/DI Not Applicable, Serial Numbers: NT3BG2000001BH; , UDI/DI To be provided, Serial Numbers: NT3BG2100002BH; : Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3BG2000002BH; j) NM/CT 850 3/8 inch ROW: Catalog number 5376204-50-1, UDI/DI Not Applicable, Serial Numbers: NT3BG2100005BH, NT3BG1900002BH; Catalog number H3907AD, UDI/DI Not Applicable, Serial Numbers: 850Y61022, 850Z61046, 850Y61008; UDI/DI To be provided, Serial Numbers: 850B61100; k) NM/CT 850 3/8 inch ROW: Catalog number 5782013, UDI/DI To be provided, Serial Numbers: 860Y62008; l) NM/CT 850 CT 850 3/8 inch: Catalog number 5782013, UDI/DI To be provided, Serial Numbers: 850A61092, 850B61108, 850B61096, 850A61080, 850Z61050, 850B61106, 850B61097, 850A61077, 850B61118, 860B62112; Catalog number 5376204-50, UDI/DI 010084068214077521850A6109511211200, Serial Numbers: 850A61095; UDI/DI 010084068214077521850A6108811210900, Serial Numbers: 850A61088; UDI/DI 010084068214077521850B6112111220700, Serial Numbers: 850B61121; UDI/DI 010084068214077521850B6110411220400, Serial Numbers: 850B61104; UDI/DI 010084068214077521850A6108711210900, Serial Numbers: 850A61087; UDI/DI 010084068214077521850A6108211210800, Serial Numbers: 850A61082; UDI/DI 010084068214077521850B6110511220400, Serial Numbers: 850B61105; Catalog number H3907AA, UDI/DI To be provided, Serial Numbers: 850A61081; Catalog number H3907AD, UDI/DI Not Applicable, Serial Numbers: 850Z61049, 850A61066; UDI/DI To be provided, Serial Numbers: 850B61098, 850B61099, 850A61084, 850B61123, 850B61113, 850B61117, 850B61116, 850A61090, 850A61079, 850A61091, 850B61114, 850A61078, 850A61086; : Catalog number To be provided, UDI/DI To be provided, Serial Numbers: 850B61125, 850B61103; m) NM/CT 850 ES 3/8 inch: Catalog number 5782013, UDI/DI To be provided, Serial Numbers: 85EA67068; Catalog number 5376204-50, UDI/DI 01008406821407752185EA6707411210800, Serial Numbers: 85EA67074, 85EA67067, 85EA67073; Catalog number 5376204-50-1, UDI/DI To be provided, Serial Numbers: NT3BG1900003BH; Catalog number H3907AA, UDI/DI To be provided, Serial Numbers: 85EA67071; Catalog number H3907AD, UDI/DI Not Applicable, Serial Numbers: 85EX67007; UDI/DI To be provided, Serial Numbers: 85EA67069, 85EA67072, 85EA67079, 85EB67084; n) NM/CT 850 ES 3/8 inch ROW: Catalog number H3907AD, UDI/DI Not Applicable, Serial Numbers: 85EZ67059, 85EA67064, 85EY67034; o) NM/CT 860 3/8 inch: Catalog number H3908AD, UDI/DI To be provided, Serial Numbers: 00000860Z62033; p) NM/CT 860 3/8 inch BJ: Catalog number H2408AA, UDI/DI To be provided, Serial Numbers: NT3CG2000001BH; Catalog number 5376204-60-1, UDI/DI Not Applicable, Serial Numbers: NT3CG2100001BH, NT3CG1900010BH, NT3CG2100003BH, NT3CG1900005BH, NT3CG1900003BH, NT3CG2100004BH, NT3CG1900006BH, NT3CG2100005BH, NT3CG2000004BH, NT3CG1900002BH, NT3CG2100002BH; q) NM/CT 860 3/8 inch ROW: Catalog number 5782013, UDI/DI To be provided, Serial Numbers: 00000860Y62018; Catalog number H3908AD, UDI/DI Not Applicable, Serial Numbers: 860A62056, 860Y62011, 860A62048, 860Z62039, 860Z62044, 860A62052, 860A62055, 860Y62012, 860Y62022, 860A62054; Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3CG2000003BH; UDI/DI To be provided, Serial Numbers: 860B62102; r) NM/CT 860 ADVANCE: Catalog number H3908AD, UDI/DI Not Applicable, Serial Numbers: 860Z62045, 860A62064, 860A62061; UDI/DI To be provided, Serial Numbers: 860A62075; Catalog number H3908BB , UDI/DI Not Applicable, Serial Numbers: 8BBB30002, 8BBB30001; s) NM/CT 860 advance 3/8 inch NM Gantry: Catalog number H3908BB, UDI/DI To be provided, Serial Numbers: 8BBB30003, 8BBB30004; t) NM/CT 860 BEYOND: Catalog number H3908BC, UDI/DI Not Applicable, Serial Numbers: 8BCB40001; u) NM/CT 860 beyond 3/8 inch NM Gantry: Catalog number H3908BC, UDI/DI To be provided, Serial Numbers: 8BCB40002; v) NM/CT 860 China for China: Catalog number 5376204-60-1, UDI/DI Not Applicable, Serial Numbers: NT3CG2200004BH, NT3CG2200003BH, NT3CG2200002BH; , UDI/DI To be provided, Serial Numbers: NT3CG2200001BH; w) NM/CT 860 CT 860 3/8 inch: Catalog number 5782013, UDI/DI To be provided, Serial Numbers: 860B62109, 860Z62029, 860B62101, 860B62113; Catalog number H3908AD, UDI/DI Not Applicable, Serial Numbers: 860Z62036, 86EZ76001, 860A62053; UDI/DI To be provided, Serial Numbers: 860B62092, 860A62088; x) NM/CT 860 ES 3/8 inch: Catalog number 5782013, UDI/DI To be provided, Serial Numbers: 86EB76005; y) NM/CT 860 ES 3/8 inch ROW: Catalog number H3908AD, UDI/DI Not Applicable, Serial Numbers: 86EA76002; z) NM/CT 850 3/8 inch: Catalog number H3907AA, UDI/DI Not Applicable, Serial Numbers: 850Y61024; aa) NM/CT 850 ES 3/8 inch ROW: Catalog number H3907AH, UDI/DI Not Applicable, Serial Numbers: 85EY67030; bb) NM/CT 860 3/8 inch CH: Catalog number H2408AA, UDI/DI Not Applicable, Serial Numbers: NT3DG1900007BH; cc) XELERIS 4 DR WORKSTATION: Catalog number 5782013, UDI/DI To be provided, Serial Numbers: 850B61124, 850A61094
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated