{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "161031", "product_res_number": "Z-0532-2018", "event_date_initiated": "2018-01-17", "event_date_posted": "2018-01-25", "recall_status": "Terminated", "event_date_terminated": "2018-11-29", "res_event_number": "78989", "product_code": "MSX", "k_numbers": [ "K141156" ], "product_description": "Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection or alarms)\n\nThe Spacelabs Healthcare Telemetry Receiver, Model 96280, is intended to provide the Spacelabs Healthcare monitoring system with adult, pediatric and neonatal patient data of patients connected to Spacelabs Healthcare telemetry transmitters. Data includes physiological waveforms and calculations, cardiac arrhythmia and ST data, and patient demographic information to monitor adequacy of treatment or to exclude causes of symptoms.", "code_info": "Serial numbers: 6280-000359, 6280-000340, 6280-000336, 6280-000503, 6280-000502, 6280-000500, 6280-000496, 6280-000495, 6280-000327, 6280-000260, 6280-000566, 6280-000290", "firm_fei_number": "3010157426", "recalling_firm": "Spacelabs Healthcare Inc", "address_1": "35301 SE Center St", "city": "Snoqualmie", "state": "WA", "postal_code": "98065-9216", "reason_for_recall": "Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station resulting in a loss of monitoring.", "root_cause_description": "Under Investigation by firm", "action": "On January , 2018, a customer letter was sent via priority service, return receipt requested, to all U.S. customers. International consignees will be notified on January 24 , 2018, by email. \n\nThe letter stated: \" Please weigh the benefits versus the risks when deciding whether or not to continue to use your Exhibit Telemetry Receiver(s) until updated as set forth below. \n\nWe recommend that you brief your staff regarding the failure mode listed above.\" Spacelabs Healthcare will contact you to schedule a convenient time for Spacelabs to update your Exhibit Telemetry Receiver(s) to software version 1.0.2 at no cost.\" For further questions, please call (800) 522-7025.", "product_quantity": "12 systems", "distribution_pattern": "US Distribution to the states of : VA, NJ, MI, GA, and Internationally to France", "openfda": { "k_number": [ "K071391", "K180430", "K974101", "K150632", "K112282", "K070204", "K171322", "K190073", "K173203", "K042771", "K242728", "K243270", "K070421", "K012005", "K973640", "K011999", "K982342", "K261367", "K033281", "K193391", "K061428", "K001972", "K183238", "K160862", "K253654", "K151672", "K020524", "K110521", "K000647", "K071047", "K973527", "K061932", "K143057", "K971868", "K010912", "K212622", "K052972", "K093925", "K211949", "K241397", "K102974", "K971569", "K992749", "K051283", "K052854", "K193043", "K193421", "K020018", "K112047", "K042845", "K033078", "K231506", "K040945", "K100376", "K974567", "K111296", "K182637", "K012531", "K060254", "K140852", "K162607", "K080192", "K192952", "K121885", "K242750", "K153156", "K052975", "K180566", "K213863", "K061994", "K012171", "K990378", "K992848", "K973318", "K130707", "K130339", "K242842", "K103634", "K994430", "K260211", "K972880", "K141756", "K971683", "K161164", "K121865", "K233418", "K202497", "K151006", "K210160", "K003998", "K032346", "K013156", "K233834", "K210133", "K962473", "K203579", "K013246", "K111215", "K051634", "K030615", "K112650", "K232548", "K220058", "K020661", "K102757", "K022507", "K121712", "K211046", "K091176", "K032582", "K062278", "K142935", "K191272", "K132036", "K182543", "K023497", "K013387", "K223567", "K222550" ], "registration_number": [ "", "3013546957", "3013896610", "3014856521", "2221819", "2183613", "9610816", "3010698831", "3006104191", "3010703925", "3009831876", "3038761440", "3044754336", "3015173634", "1000122786", "3011696573", "3001104093", "3009673645", "9611252", "3005783425", "3009156722", "3011166598", "3013783488", "2032233", "3000126629", "3003263092", "3016618143", "3015134004", "3009595635", "3013500228", "9680215", "3004906872", "3015437214", "1316463", "3016852448", "3006240053", "3001570235", "3012528160", "1218950", "3016701404", "3012359877", "3008729547", "1831750", "3008855170", "3009443693", "3013596024", "3000976525", "3016670256", "3018188848", "3008952681", "3027510187", "3004091281", "3009499478", "1651104", "3007603826", "3009077524", "3016595211", "3011353843", "9610105", "3015529350", "9611500", "3007481893", "3008058135", "3010157426", "9681377", "3014541700", "3007413079", "3003971136", "2080783", "3013501110", "8020045", "3019388613", "3009973336", "3004526608" ], "fei_number": [ "", "3013546957", "3013896610", "3014856521", "2221819", "2183613", "3010698831", "3023530182", "3006104191", "3010703925", "3009831876", "3038761440", "3044754336", "1000300598", "3015173634", "1000122786", "3011696573", "3001104093", "3009673645", "3005783425", "3009156722", "3011166598", "3013783488", "3000126629", "3001084824", "3003263092", "3016618143", "3015134004", "3009595635", "3013500228", "1316463", "3004906872", "3015437214", "3016852448", "6736", "3006240053", "3003142870", "3001570235", "3012528160", "3002737156", "1218950", "3016701404", "3012359877", "3008729547", "1831750", "3008855170", "3009443693", "3013596024", "3000976525", "3016670256", "3018188848", "3002806783", "3008952681", "3027510187", "3006254866", "3009499478", "3007603826", "3009077524", "3016595211", "3011353843", "3007481893", "3015529350", "3008058135", "3010157426", "3014541700", "3007413079", "3003971136", "3002807720", "2080783", "3002807167", "3013501110", "3019388613", "3009973336", "3004526608" ], "device_name": "System, Network And Communication, Physiological Monitors", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.2300", "device_class": "2" } } ] }