{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "219564", "product_res_number": "Z-2052-2026", "event_date_initiated": "2026-03-26", "event_date_posted": "2026-05-01", "recall_status": "Open, Classified", "res_event_number": "98722", "product_code": "DSI", "k_numbers": [ "K103142" ], "product_description": "Brand Name: Spacelabs Ultraview SL Command Module\nProduct Name: SL Command Module\nModel/Catalog Number: 91496\nSoftware Version: N/A\nProduct Description: The Command Module (91496) is the core of the Spacelabs patient monitoring system, providing the processing power for all basic physiologic parameters. The Command Module inserts into the side of a Spacelabs patient monitor. A variety of configurations can be selected to suit the monitoring needs of specific patients or care units in the hospital.\nComponent: N/A", "code_info": "Model/Catalog Number: 91496\nUDI-DI Code: (01)10841522106422\nSerial Numbers:\n1496-224669\t1496-224670\t1496-224657\t1496-224658\t1496-224659\t1496-224660\t1496-224661\t1496-224671\t1496-224673\t1496-224674 1496-224675\t1496-224676\t1496-224677\t1496-224678\t1496-224679\t1496-224680\t1496-224681\t1496-224682\t1496-224683\t1496-224684 1496-224685\t1496-224686\t1496-224687\t1496-224688\t1496-224689\t1496-224690\t1496-224691\t1496-224692\t1496-224693\t1496-224694 1496-224695\t1496-224696\t1496-224697\t1496-224698\t1496-224699\t1496-224701\t1496-224702\t1496-224703\t1496-224704\t1496-224705 1496-224706\t1496-224707\t1496-224708\t1496-224709\t1496-224710\t1496-224711\t1496-224712\t1496-224713\t1496-224714\t1496-224715 1496-224716\t1496-224664\t1496-224665\t1496-224666\t1496-224667\t1496-224668", "firm_fei_number": "3010157426", "recalling_firm": "Spacelabs Healthcare, Inc.", "address_1": "35301 Se Center St", "city": "Snoqualmie", "state": "WA", "postal_code": "98065-9216", "additional_info_contact": "Brad Chen\n+1-425-3963300", "reason_for_recall": "Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).", "root_cause_description": "Process control", "action": "On 03/26/2026, the firm sent via email an URGENT MEDICAL DEVICE CORRECTION Letter to customers informing them that Spacelabs Healthcare became aware that for certain Multi-Parameter Command Modules (Model 91496) manufactured between 07/17/2025 to 08/05/2026 using a malfunctioning test equipment resulting in inadequate electrical leakage testing.\n\nCustomers are instructed to:\n1.Notify Please notify all relevant employees within your organization, including facilities you have distributed the products to, of this medical device correction notice and to cease use of the modules identified in Appendix B.\n2.Acknowledge Please acknowledge receipt of this notice by either utilizing the URL/QR code listed in Appendix A or completing the paper acknowledgement form and returning it via one of the methods outlined in the form.\n3.Segregate Identify and Quarantine the affected devices listed in Appendix B.\n4.Report Contact your local Spacelabs Healthcare service representative to coordinate your device correction as soon as possible.\n\nTo remedy the issue identified in this letter, Spacelabs Healthcare will be replacing the impacted devices with brand new units of the same specification.\n\nFor questions - call Phone: 1-800-522-7025\nWebsite: https://spacelabshealthcare.com/support/", "product_quantity": "57", "distribution_pattern": "Worldwide - US Nationwide di GA, KS, MI, OH, SC, TX, WA and the country of ARGENTINA.", "openfda": { "k_number": [ "K860078", "K860834", "K980186", "K830029", "K913576", "K974792", "K830163", "K891148", "K071889", "K182532", "K830306", "K982697", "K895266", "K803282", "K012336", "K153473", "K864506", "K071655", "K844791", "K880505", "K942147", "K012241", "K082633", "K970348", "K152550", "K974698", "K781911", "K020550", "K960884", "K896862", "K011824", "K053263", "K944350", "K062976", "K151681", "K012461", "K781845", "K152491", "K231276", "K900246", "K873533", "K920743", "K173969", "K000822", "K961165", "K844464", "K970585", "K843731", "K952912", "K983980", "K955023", "K772360", "K920790", "K952885", "K910929", "K001359", "K822616", "K843503", "K852250", "K052288", "K791632", "K832772", "K871572", "K962827", "K771374", "K003576", "K860767", "K811122", "K070260", "K885204", "K860471", "K810027", "K002758", "K854115", "K090037", "K001120", "K945429", "K812914", "K840899", "K151835", "K843513", "K900366", "K980882", "K801831", "K790837", "K014159", "K834211", "K890338", "K862316", "K863724", "K910291", "K990125", "K121197", "K897074", "K243349", "K851517", "K842640", "K870816", "K925411", "K903704", "K830830", "K090834", "K955743", "K945384", "K874768", "K884106", "K850897", "K790287", "K871890", "K970358", "K865030", "K023798", "K150310", "K113125", "K964832", "K250356", "K852884", "K884524", "K802900", "K760368", "K841500", "K001333", "K101703", "K896771", "K802033", "K903940", "K002604", "K872241", "K884643", "K920154", "K951371", "K974747", "K830407", "K112921", "K091927", "K852654", "K972502", "K021251", "K952417", "K981376", "K831638", "K881488", "K001436", "K802472", "K942058", "K150117", "K173170", "K852892", "K896967", "K993516", "K760884", "K925510", "K140548", "K860024", "K885256", "K990972", "K141441", "K935877", "K842976", "K820477", "K823586", "K871344", "K033305", "K240177", "K830013", "K032370", "K965062", "K863159", "K895208", "K124060", "K882978", "K864149", "K862375", "K964624", "K822968", "K103142", "K993757", "K914092", "K983632", "K230265", "K823585", "K152305", "K152701", "K803208", "K832354", "K912744", "K001057", "K853213", "K991773", "K993171", "K972282", "K052160", "K853669", "K102111", "K860950", "K882513", "K923747", "K000779", "K900607", "K131000", "K951370", "K802103", "K812149", "K852883", "K110499", "K971131", "K864505", "K992637", "K871025", "K931716", "K801762", "K111160", "K003246", "K910490", "K872497", "K842616", "K193104", "K811527", "K964593", "K810940", "K882206", "K933177", "K103764", "K031433", "K842123", "K011784", "K821711", "K871251", "K102507", "K974510", "K192732", "K962970", "K890323", "K820856", "K946306", "K900385", "K964122", "K911835", "K952054", "K802272", "K071995", "K013046", "K032858", "K021300", "K002068", "K840622", "K964187", "K852968", "K883440", "K862947", "K021097", "K872837", "K954852", "K832693", "K011339", "K841084", "K100155", "K935846", "K853352", "K903514", "K831274", "K820438", "K962291", "K900319", "K930095", "K905506", "K841172", "K900540", "K897063", "K120774", "K820881", "K881905", "K151188", "K883410", "K050605", "K935732", "K822718", "K780432", "K992908", "K896103", "K081257", "K961139", "K780343", "K972714", "K091971", "K142180", "K955059", "K865032", "K895806", "K945944", "K071805", "K942196", "K022453", "K972498", "K971910", "K896775", "K913451", "K093766", "K864401", "K813287", "K922027", "K950821", "K083517", "K890330", "K792081", "K884887", "K132407", "K834597", "K020084", "K884152", "K860167", "K003179", "K894858", "K982730", "K910808", "K143359", "K850136", "K151269", "K841416", "K801903", "K863643", "K861240", "K853209", "K842715", "K854282", "K924672", "K851702", "K791424", "K834397", "K960418", "K822030", "K900720", "K071641", "K050919", "K000746", "K101639", "K092947", "K880664", "K841083", "K860079", "K855094", "K993531", "K823844", "K984089", "K881273", "K082475", "K142352", "K882818", "K791487", "K963057", "K980429", "K980625", "K915153", "K894628", "K811581", "K852514", "K811792", "K081444", "K894543", "K894285", "K884539", "K083287", "K883103", "K073140", "K802312", "K860470", "K970545", "K884216", "K980045", "K190574", "K873874", "K012467", "K895547", "K894692", "K894460", "K910109", "K873680", "K993383", "K860980", "K871389", "K852270", "K944422", "K181658", "K050175", "K843287", "K153477", "K831676", "K021376", "K833162", "K024213", "K980728", "K913339", "K962404", "K970920", "K913117", "K970012", "K990093", "K852207" ], "registration_number": [ "3011120183", "1033601", "3009156722", "3012238587", "3008716327", "3010041430", "3010112812", "3007048291", "3006979678", "3008729547", "2182208", "2221819", "3016674095", "3013791928", "3003589956", "1218950", "3043543260", "9710602", "3008494315", "3010157426", "3018783526", "1651104", "1219324", "3016812424", "9611031", "9681377", "3021769057", "3010536822", "3022298579", "3016852448", "3012528160", "3009883402", "3010390468", "3008363989", "3004009431", "3015328411", "3009673645", "3010863450", "3004188066", "9610816", "3014541700", "3009959868", "3023272766", "3007836437", "3009607734", "3008773647", "3011937459", "3010703925", "3029904429", "3008973940", "3022123357", "3010120148", "3005783425", "3010698831", "2017865", "3032109181", "9610105", "3016701404", "1833920", "3007413079", "3007208829", "3008483389", "1930027", "3004977335", "3013500228", "3007770164", "8030229", "3013679558", "3004574071", "3008642652", "3007305624", "3013783488", "3010082909", "3013896610", "3012359877", "9614453", "3001570235", "3007734888", "3023164", "3031162043", "1527715", "3010120135", "3015181391", "3009077524", "3027815", "3011353843", "9611252", "3004185781", "3012552532", "3031158", "3007603826", "3009499478", "3005877899", "3009380063", "1316463", "2080783", "3010032903", "3012606445", "3000126629", "1066270", "3010381606", "2028530", "1037137", "1000425315", "1000122786", "3016618143", "2133409", "3009831876", "3005737664", "3013889955", "3003584029", "3017942784", "3004415095", "3004593495", "3019388613", "3009490946", "3003263092", "3013501110", "3013596024", "3003971136" ], "fei_number": [ "3011120183", "1033601", "3009156722", "3012238587", "1000115656", "3008716327", "3010041430", "3010112812", "3007048291", "3006979678", "3008729547", "2182208", "2221819", "3016674095", "3013791928", "3003589956", "1218950", "3043543260", "3002807739", "3010157426", "3018783526", "1219324", "3016812424", "3002806783", "3010830833", "3021769057", "3010536822", "3022298579", "3016852448", "3012528160", "3009883402", "3010390468", "3008363989", "3004009431", "3015328411", "3009673645", "3010863450", "3004188066", "3014541700", "3009959868", "3000215024", "3023272766", "3007836437", "3009607734", "3008773647", "3011937459", "3010703925", "3029904429", "3008973940", "3010120148", "3005783425", "3010698831", "2017865", "3032109181", "3008377825", "3016701404", "3000957797", "3007413079", "3007208829", "3008483389", "1930027", "3004977335", "3013500228", "3007770164", "3013679558", "1000520785", "3004574071", "3008642652", "3007305624", "3013783488", "3010082909", "3002807576", "3013896610", "3012359877", "3001570235", "3007734888", "3002807167", "3023164", "3031162043", "1527715", "3010120135", "3015181391", "3009077524", "3011353843", "3004185781", "3012552532", "3007603826", "3009499478", "3002807019", "3005877899", "3002737156", "3009380063", "1000127185", "1316463", "2080783", "3010032903", "3012606445", "3000126629", "3010381606", "1037137", "3002807720", "1000425315", "1000122786", "3016618143", "3009831876", "3005737664", "1000300598", "3013889955", "3003584029", "3017942784", "3004415095", "3004593495", "3019388613", "3009490946", "3003263092", "1000125122", "3013501110", "3013596024", "3003971136", "3003513129" ], "device_name": "Detector And Alarm, Arrhythmia", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1025", "device_class": "2" } } ] }