{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 6 } }, "results": [ { "cfres_id": "197809", "product_res_number": "Z-1053-2023", "event_date_initiated": "2022-12-19", "event_date_posted": "2023-02-08", "recall_status": "Open, Classified", "res_event_number": "91456", "product_code": "KPS", "k_numbers": [ "K093514" ], "product_description": "GE Nuclear Medicine 600/800 series systems, specifically: \na)\t870, \nb)\t870 DR 3/8 inch NM GANTRY WITH NEW ROTOR - MEA, \nc)\t870 DR / Dismount, \nd)\t870 DR / Dismount / 60HZ, \ne)\t870 DR 3/8 inch WSO, \t\nf)\t870 DR 3/8 inch NM Gantry, \ng)\t870 DR 3/8 inch, \nh)\t870 DR 3/8 inch CH, \ni)\t870 DR 5/8 inch NM GANTRY, \nj)\t870 DR BJ / Dismount, \nk)\t870 DR CyberDefense 3/8 inch NM Gantry, \nl)\t870 DR NM GANTRY FINAL - NEW ROTOR, \nm)\t870 DR China, \nn)\tD670 NM GANTRY WITH NEW ROTOR, \no)\tD670 DR 3/8 inch 16 SL, \np)\tD670 DR 3/8 inch MEA, \nq)\tD670 DR 3/8 inch, \nr)\tD670 DR 3/8 inch 16SL, \ns)\tD670 DR 3/8 inch 16SL NR, \nt)\tD670 DR 3/8 inch BJ, \nu)\tD670 DR 3/8 inch MEA, \nv)\tD670 DR NM Gantry 3/8 inch, \nw)\tD670 DR NM Gantry 5/8 inch, \nx)\tD670 DR with new rotor, \ny)\tD670 ES NM Gantry 3/8 inch, \nz)\tD670 ES NM/CT 3/8 inch O540+ NM Gantry, \naa)\tD670 ES NM/CT DR 3/8 inch, \nbb) \tD670 GANTRY, \ncc)\tD670 PRO NM Gantry 3/8 inch, \ndd) \tD670 PRO NM GANTRY 3/8 inch, \nee)\tDISC NM/CT670 DR 3/8 inch, \nff)\tDISC NM/CT870 DR 3/8 inch, \ngg)\tDISC NM/CT870 DR 3/8 inch, \nhh) \tDISC NM/CT870 DR 5/8 inch, \nii)\tDISCOVERY 670 (TANDEM), \njj)\tDISCOVERY NM 670, \nkk)\tDISCOVERY NM/CT 670 3/8 inch PRO, \nll)\tDISCOVERY NM/CT 670 3/8 inch PRO NR, \nmm) \tHP Z420 WS Config 1 Hardware Specs Take 3 - E5-1620-8G-1TB-NVS, \nnn) \tNM/CT 870 DR, \noo) \tNM/CT 870 DR 3/8 inch CYBER DEFENCE, \npp) \tNM/CT 870 DR 3/8 inch WSO, \nqq) \tNM/CT 870 DR O540 3/8 inch, \nrr)\tNM/CT 870 DR O540 3/8 inch BJ, \nss)\tNM/CT 870 DR O540 5/8 inch, \ntt)\tNM/CT 870 ES 3/8 inch, \nuu) \tNM/CT 870DR China for China, \nvv)\tNM/CT870 DR 3/8 inch O540, \nww) \tNM/CT D870 DR O540 3/8 inch, \nxx)\tTANDEM DISCOVERY 670 INT; \nEmission Computed Tomography System", "code_info": "a)\t870: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3DG2200004, NT3DG2200009, NT3DG2200018, NT3DG2200002; \nb)\t870 DR 3/8\" NM GANTRY WITH NEW ROTOR - MEA: Catalog number 5376204-70-60-1, UDI/DI Not Applicable, Serial Numbers: NT3DG2100018BH; \nc)\t870 DR / Dismount: Catalog number To be provided, UDI/DI To be provided, Serial Numbers: NT3DG2100006; \nd)\t870 DR / Dismount / 60HZ: Catalog number To be provided, UDI/DI To be provided, Serial Numbers: NT3DG2000016BH; \ne)\t870 DR 3/8\" WSO: Catalog number H3906EM, UDI/DI Not Applicable, Serial Numbers: 870B64224, 870Z64148; \nf)\t870 DR 3/8\" NM Gantry: Catalog number H3100AS, UDI/DI Not Applicable, Serial Numbers: 870Y64064, 870Y64040, 870A64172, 870Z64145, 870A64161, 870Z64111, 870Z64126, 870Y64081, 870A64210, 870X64003, 870A64180, 870Y64047, 870Y64044, 870Y64079, 870Y64050, 870Z64130, 870X64011, 870Y64095, 870Y64037, 870Y64074, 870Y64067, 870Y64051, 870A64162, 870X64024, 870A64163, 870A64165, 870X64002, 870Y64072, 870Z64107, 870Z64108, 870X64032, 870A64192, 870A64183, 870A64164, 870B64229, 870A64176, 870A64185, 870Z64137, 870Z64117, 870X64001, 870Y64055, 870Y64088, 870B64235, 870Y64078, 870Y64080, 870Z64125, 870Z64098, 870A64204, 870A64205, 870B64306, 870B64305, 870A64182, 870B64261, 870Y64069, 870Z64104, 870Y64042, 870Y64039, 870Y64086, 870Z64146, 870A64179, 870Y64085, 870A64168, 870Z64103, 870Y64094, 870Z64101, 870A64160, 870B64300, 870Y64046, 870B64302, 870A64199, 870Y64056, 870Z64121, 870A64174, 870X64004, 870X64012, 870X64007, 870Y64048, 870X64009, 870Z64124, 870X64026, 870Z64119, 870Z64122, 870Y64049, 870Y64089, 00000870Y64035, 870Z64134, 870Y64052, 870Y64076, 870Y64063, 870A64159, 870Z64133, 870B64286, 870B64247, 870B64244, 870A64184, 870B64240, 870B64264, 870B64287, 870A64196, 870A64187, 870B64307, 870A64208, 87EB77017, 870X64016, 870X64005, 870Z64136, 870Y64033, 870A64153, 870A64154, 870B64227, 870Y64091, 870B64231, 870B64292, 870Z64149, 87EA77011, 870X64022, 870Y64053, 870Z64114, 870Z64115, 87EZ77003, 87EB77016, 87EZ77004, 870B64233, 870Z64141, 87EB77014, 870A64175, 87EB77015, 870X64019, 870A64188, 870Y64059, 870Y64068, 870Y64071, 870Y64082, 870B64265, 870Z64102, 870X64020, 870Y64090, 870B64262, 870B64274, 870B64268, 870B64275, 870Z64128, 870B64270, 870B64271, 870B64272, 870B64273, 870B64266, 870B64280, 870B64267, 870Z64116, 870B64276, 870B64277, 870B64278, 870B64279, 870B64269, 870B64281, 870B64282, 870B64283, 870Z64142, 870Y64065, 870A64158, 870X64025, 87EZ77001, 870Z64120, 870Y64038, 870B64236, 870Y64077, 870A64202, 870A64207, 870B64251, 870B64221, 870A64197, 870X64010, 870Y64073, 870Y64036, 870Y64092, 870Y64087, 870X64027, 870X64029, 870Y64084, 870X64030, 870X64023, 870X64028, 87EA77010, 87EA77012, 870B64222, 870A64155, 870B64226, 870B64225, 87EB77018, 870B64297, 870B64299, 870B64293, 87EB77019, 870B64258, 870A64209, 87EZ77007, 870B64253, 870A64217, 870Z64127, 870B64285, 870Y64083, 870B64257, 870B64259, 870X64013, 870B64252, 870Z64105, 870Y64061, 870B64284, 870B64254, 870B64260, 870B64308, 870B64296, 870B64303, 870Z64110, 870Z64144, 870Y64075, 870A64171, 870A64215, 870A64212, 870Z64129, 870X64021, 870A64198, 870B64230, 870Z64113, 870Z64131, 870Z64132, 870Y64070, 870Z64140, 870B64263, 870B64294, 870A64190, 870Y64058, 870B64241, 870Z64135, 870Y64097, 870Z64099, 870Z64151, 870Y64057, 870A64157, 870B64242, 870B64243, 870B64250, 870Z64109, 870B64237, 870Z64106, 870A64173, 870X64008, 870A64152, 870B64218, 870B64234, 870B64238, 870B64239, 870A64200; \ng)\t870 DR 3/8\": Catalog number H3100AP, UDI/DI Not Applicable, Serial Numbers: 870Y64034; UDI/DI 010084068214083621870X6401511180900, Serial Numbers: 870X64015; \nh)\t870 DR 3/8\" CH: Catalog number H2402AG, UDI/DI To be provided, Serial Numbers: NT3DG1900005BH; UDI/DI Not Applicable, Serial Numbers: NT3DG1800002BH; \ni)\t870 DR 5/8\" NM GANTRY: Catalog number H3100Q, UDI/DI 010084068214083621870X6401811181000, Serial Numbers: 870X64017; UDI/DI 010084068214083621870Y6406611190700, Serial Numbers: 870Y64066; UDI/DI Not Applicable, Serial Numbers: 870Y64045, 870A64201, 00000870X64014, 870Y64041; \nj)\t870 DR BJ / Dismount: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3DG1900013BH; \nk)\t870 DR CyberDefense 3/8\" NM Gantry: Catalog number H3906FF, UDI/DI Not Applicable, Serial Numbers: 87CA83004, 87CA83001; , UDI/DI To be provided, Serial Numbers: 87CA83002, 87ZA83005; \nl)\t870 DR NM GANTRY FINAL - NEW ROTOR: Catalog number H3100AS, UDI/DI To be provided, Serial Numbers: \t870B64288, 00000870Z64139; \nm)\t870 DR China: Catalog number To be provided, UDI/DI To be provided, Serial Numbers: NT3DG2100016BH; \nn)\tD670 NM GANTRY WITH NEW ROTOR: Catalog number 5791566, UDI/DI To be provided, Serial Numbers: 870A64203, 87EA77013, 870B64255; \no)\tD670 DR 3/8\" 16 SL: Catalog number 5791566, UDI/DI To be provided, Serial Numbers: DRGY56031, DRGY56025; UDI/DI Not Applicable, Serial Numbers: \t00000DRGZ56044; \nCatalog number H3100BT, UDI/DI To be provided, Serial Numbers: 00000DRGX56017, 00000DRGZ56042; UDI/DI 010084068213935921DRGY5603011190700, Serial Numbers: DRGY56030; \np)\tD670 DR 3/8\" MEA: Catalog number 5376204-70-61-1, UDI/DI To be provided, Serial Numbers: NT2RG1900005BH; \nq)\tD670 DR 3/8\": Catalog number H3100AK, UDI/DI Not Applicable, Serial Numbers: \t00000589470GE4; \nr)\tD670 DR 3/8\" 16SL: Catalog number 5791566, UDI/DI Not Applicable, Serial Numbers: DRGY56024; Catalog number H3100BT, UDI/DI Not Applicable, Serial Numbers: DRGY56026, DRGX56023, DRGX56009, DRGZ56047, DRGZ56049, DRGZ56045, DRGZ56051, DRGZ56056, DRGZ56046; \ns)\tD670 DR 3/8\" 16SL NR: Catalog number H3100BT, UDI/DI Not Applicable, Serial Numbers: DRGZ56050; \nt)\tD670 DR 3/8\" BJ: Catalog number 5376204-70-61-1, UDI/DI Not Applicable, Serial Numbers: NT2RG1800002BH, UDI/DI 01008406821393111119030021NT2RG1900001BH, Serial Numbers: NT2RG1900001BH; \nu)\tD670 DR 3/8\" MEA: Catalog number 5376204-70-61-1, UDI/DI To be provided, Serial Numbers: NT2RG2200001BH; \nv)\tD670 DR NM Gantry 3/8\": Catalog number H3100BT, UDI/DI Not Applicable, Serial Numbers: DRGX56002, DRGY56028, DRGX56005, DRGY56033, DRGX56004, DRGY56037, DRGX56003, DRGX56008, DRGX56007, DRGY56033, DRGZ56039, DRGX56011, DRGX56006, DRGX56021, DRGZ56054, DRGZ56040, DRGY56038, DRGY56032, DRGX56019, DRGZ56052, DRGX56012, DRGY56029, DRGY56027, DRGZ56048, DRGX56014, DRGZ56053, DRGZ56055, DRGY56034, DRGX56020, DRGX56016, DRGY56036, DRGX56022, DRGX56015, DRGZ56041; UDI/DI To be provided, Serial Numbers: DRGX56018, DRGA56057, DRGA56058; UDI/DI 010084068213935921DRGY5603511190900, Serial Numbers: DRGY56035; UDI/DI 010084068213935921DRGZ5604311200400, Serial Numbers: DRGZ56043; \nw)\tD670 DR NM Gantry 5/8\": Catalog number\tH3100CM, UDI/DI Not Applicable, Serial Numbers: DRGX56010; \nx)\tD670 DR with new rotor: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT2RG1900003, NT2RG2000001BH; \ny)\tD670 ES NM Gantry 3/8\": Catalog number H3100XF, UDI/DI Not Applicable, Serial Numbers: ESGY53002, ESGY53001, ESGY53003, ESGZ53005, ESGA53008, ESGB53011, ESGZ53004, ESGA53007, ESGZ53006, ESGA53010, ESGA53009; \nz)\tD670 ES NM/CT 3/8\" O540+ NM Gantry, \naa)\tD670 ES NM/CT DR 3/8\": Catalog number H3100BM, UDI/DI Not Applicable, Serial Numbers: ESPX54001, ESPY54002; \nbb) D670 GANTRY: Catalog number H3100BM\t, UDI/DI Not Applicable, Serial Numbers: ESPY54003; \ncc)\tD670 PRO NM Gantry 3/8\": Catalog number H3100NC, UDI/DI UDI Not Required, Serial Numbers: 21128; \ndd) D670 PRO NM GANTRY 3/8\": Catalog number H3100XB, UDI/DI Not Applicable, Serial Numbers: PRGZ52045, PRGY52027, PRGA52061, PRGY52021, PRGY52023, PRGY52018, PRGZ52057, PRGY52013, PRGZ52048, PRGY52020, PRGZ52058, PRGX52008, PRGZ52046, PRGA52063, PRGA52068, PRGX52007, PRGZ52047, PRGZ52059, PRGA52066, PRGA52070, PRGY52039, PRGY52012, PRGZ52051, PRGX52004, PRGZ52055, PRGY52016, PRGX52009, PRGY52015, PRGZ52054, PRGY52031, PRGY52036, PRGY52024, PRGY52028, PRGY52025, PRGY52037, PRGY52032, PRGY52029, PRGZ52050, PRGX52005, PRGA52064, PRGY52030, PRGZ52056, PRGA52069, PRGX52002, PRGX52006, PRGX52003, PRGA52060; , UDI/DI UDI_Not_Required_2, Serial Numbers: PRGY52035; , UDI/DI To be provided, Serial Numbers: PRGA52077, PRGA52072, PRGA52073, PRGA52075, PRGB52083, PRGA52076, PRGA52079, PRGB52080, PRGB52081, PRGB52082, PRGA52071, PRGA52074, PRGB52084, PRGA52078; UDI/DI 010084068213937321PRGX5200111180700, Serial Numbers: PRGX52001; UDI/DI 010084068213937321PRGX5201011181200, Serial Numbers: PRGX52010; UDI/DI 010084068213937321PRGY5201111190100, Serial Numbers: PRGY52011; UDI/DI 010084068213937321PRGY5201711190300, Serial Numbers: PRGY52017; \nee)\tDISC NM/CT670 DR 3/8\": Catalog number 5376204-70-61-1, UDI/DI Not Applicable, Serial Numbers: NT2RG1900002BH; UDI/DI To be provided, Serial Numbers: T2RG1900004BH; \nff)\tDISC NM/CT870 DR 3/8\": Catalog number H3100AS, UDI/DI Not Applicable, Serial Numbers: 87EA77009, 870A64177, 870A64156, 870Y64043, 870Z64112, 870Z64150; UDI/DI UDI Not Required, Serial Numbers: 870Y64096; UDI/DI To be provided, Serial Numbers: 870B64304, 00000870Z64147, 870Y64093, 870B64245; \ngg) DISC NM/CT870 DR 5/8\": Catalog number \t5791566, UDI/DI To be provided, Serial Numbers: 870X64018; \nhh) DISCOVERY 670 (TANDEM): Catalog number \tH3100XB\t, UDI/DI \tTo be provided\t, Serial Numbers: PRGZ52040; \nii)\tDISCOVERY NM 670: Catalog number 5474053, UDI/DI To be provided, Serial Numbers: 27053; \nkk)\tDISCOVERY NM/CT 670 3/8\" PRO: Catalog number H3100XB, UDI/DI Not Applicable, Serial Numbers:\tPRGZ52044, PRGA52065, PRGY52033, PRGZ52041, PRGZ52043, PRGZ52052, PRGY52026, PRGY52022, PRGY52014, PRGA52067, PRGY52034, PRGA52062; UDI/DI UDI_Not_Required_2, Serial Numbers: PRGZ52049, PRGZ52042; UDI/DI To be provided, Serial Numbers: \tPRGY52019; \nll)\tDISCOVERY NM/CT 670 3/8\" PRO NR, \nmm) HP Z420 WS Config 1 Hardware Specs Take 3 - E5-1620-8G-1TB-NVS: Catalog number H3100AS, UDI/DI To be provided, Serial Numbers:\t00000870Y64060; \nnn) NM/CT 870 DR: Catalog number H3100AS\t, UDI/DI To be provided, Serial Numbers: 87EZ77008; \noo) NM/CT 870 DR 3/8\" CYBER DEFENCE: Catalog number H3906FF, UDI/DI To be provided, Serial Numbers: \t87ZB83006, 87CA83003; \npp) NM/CT 870 DR 3/8\" WSO: Catalog number H3100AS, UDI/DI To be provided, Serial Numbers: 870A64189, 870A64216, 870B64228, 870B64220, 870B64223, 870A64181, 870A64211, 870A64213, 870B64249; Catalog number 5376204-70-60, UDI/DI 010084068214083621870A6421411211100, Serial Numbers: 870A64214; UDI/DI 010084068214083621870A6419511210900, Serial Numbers: 870A64195; UDI/DI 010084068214083621870A6419411210800, Serial Numbers: 870A64194; UDI/DI 010084068214083621870B6425611220500, Serial Numbers: 870B64256; UDI/DI 010084068214083621870A6419311210800, Serial Numbers: 870A64193; UDI/DI 010084068214083621870B6423211220200, Serial Numbers: 870B64232; UDI/DI 010084068214083621870B6424611220300, Serial Numbers: 870B64246; UDI/DI 010084068214083621870B6424811220300, Serial Numbers: 870B64248; UDI/DI 010084068214083621870A6419111210800, Serial Numbers: 870A64191; Catalog number To be provided, UDI/DI To be provided, Serial Numbers: 870B64295; \nqq)NM/CT 870 DR O540 3/8\": Catalog number 5376204-70-60-1, UDI/DI Not Applicable, Serial Numbers: NT3DG1900012BH, NT3DG2000001BH; Catalog number 5376204-70-61-1, UDI/DI Not Applicable, Serial Numbers: NT3DG2200013BH; Catalog number H3100AS, UDI/DI Not Applicable, Serial Numbers: 870X64031, 87EZ77006, 87EZ77005, 870Z64143, 870Y64062, 870Z64123, 870Z64118, 870A64169, 870A64166; : Catalog number To be provided, UDI/DI 010084068214083621870B6429111221100, Serial Numbers: 870B64291; Catalog number To be provided, UDI/DI 010084068214083621870B6430111221100, Serial Numbers: 870B64301; \nrr)\tNM/CT 870 DR O540 3/8\" BJ: Catalog number 5376204-70-60-1, UDI/DI 01008406821421201121050621NT3DG2100005BH, Serial Numbers: NT3DG2100005BH; UDI/DI Not Applicable, Serial Numbers: NT3DG1900014BH, NT3DG1900015BH, NT3DG2100010BH, NT3DG2100007BH, NT3DG2200005BH, NT3DG1900002BH, NT3DG2100011BH, NT3DG2200003BH, NT3DG2200014BH, NT3DG2000012BH, NT3DG1900001BH, NT3DG1800001BH, NT3DG2100003BH, NT3DG2200007BH, NT3DG2100001BH, NT3DG2100012BH, NT3DG2100008BH; UDI/DI To be provided, Serial Numbers: NT3DG1900009BH, NT3DG2200004BH, NT3DG2000013BH, NT3DG1900006BH, NT3DG2100002BH, NT3DG1900004BH, NT3DG1900011BH, NT3DG2100013BH; : Catalog number 5376204-70-61-1, UDI/DI Not Applicable, Serial Numbers: NT3DG2200019BH, NT3DG2000003BH, NT3DG2000005BH, NT3DG2000006BH; : Catalog number To be provided, UDI/DI Not Applicable\t, Serial Numbers: NT3DG2000004BH, NT3DG2200011BH, NT3DG2200017BH, NT3DG2000014BH; \nss)\tNM/CT 870 DR O540 5/8\": Catalog number H3100Q, UDI/DI Not Applicable, Serial Numbers: 870A64170; Catalog number 5791566, UDI/DI Not Applicable\t, Serial Numbers: 870Z64138, 870B64219; \ntt)\tNM/CT 870 ES 3/8\": Catalog number H3100AS, UDI/DI Not Applicable, Serial Numbers: \t87EZ77002; \nuu) NM/CT 870DR China for China: Catalog number 5376204-70-60-1, UDI/DI Not Applicable, Serial Numbers: NT3DG2200010BH; NT3DG2200015BH, NT3DG2100015BH, NT3DG2200006BH, NT3DG2200001BH; : Catalog number 5376204-70-61-1, UDI/DI Not Applicable, Serial Numbers: NT3DG2200016BH, NT3DG2200012BH; \nvv)\tNM/CT 870 DR 3/8\" O540: Catalog number 5376204-70-60-1, UDI/DI Not Applicable, Serial Numbers: NT3DG2000008BH, NT3DG2000010BH, NT3DG2000011BH, NT3DG2100009BH, NT3DG2100014BH, NT3DG2100004BH; Catalog number 5376204-70-61-1, UDI/DI Not Applicable, Serial Numbers: NT3DG2200008BH\nww) NM/CT D870 DR O540 3/8\": Catalog number 5376204-70-60-1, UDI/DI Not Applicable, Serial Numbers: NT3DG1900010BH, NT3DG1900003BH, NT3DG2000015BH; Catalog number \tTo be provided, UDI/DI \tNot Applicable, Serial Numbers: NT3DG2000002BH; Catalog number To be provided, UDI/DI To be provided, Serial Numbers: 870A64186; \nxx)\tTANDEM DISCOVERY 670 INT: Catalog number H3100XB, UDI/DI Not Applicable, Serial Numbers: PRGY52038.", "firm_fei_number": "3004571294", "recalling_firm": "GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING", "address_1": "4, Hayozma St 4 Hayozma St", "city": "Tirat Carmel", "country": "Israel", "additional_info_contact": "GE HealthCare Service\n800-4371171", "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.", "root_cause_description": "Process control", "action": "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: \n.GE Healthcare asks that you STOP USE of your Nuclear Medicine system, if your\nsystem is listed in the Affected Product Details and Appendix of this letter, until an\ninspection of your system is completed by GE Healthcare and you have been\nprovided with a letter indicating the system can be returned to clinical use. \n.GE Healthcare will correct all affected products at no cost to you. GE Healthcare\nwill inspect your system to ensure that the appropriate mitigation is correctly\nimplemented to address this potential life-threatening concern. A GE Healthcare\nrepresentative will contact you to arrange for this correction. \n.If you have any questions or concerns regarding this notification, please contact\nGE Healthcare Service at 1-800-437-1171 or your local Service Representative.", "product_quantity": "557 units", "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.", "openfda": { "k_number": [ "K981553", "K040141", "K031872", "K101768", "K962100", "K041218", "K083649", "K072567", "K900892", "K210880", "K942145", "K042903", "K862511", "K922427", "K202349", "K182484", "K170490", "K163394", "K081135", "K082244", 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