{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "217345", "product_res_number": "Z-0920-2026", "event_date_initiated": "2025-11-18", "event_date_posted": "2025-12-12", "recall_status": "Open, Classified", "res_event_number": "97969", "product_code": "MSX", "k_numbers": [ "K220058" ], "product_description": "Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring System (DMS). Model Number: 115-050935-00 and E115-050935-00. Software Version: Audio Driver version 6.0.9484.1\n\nHP Pro Mini 400 G9 Desktop PC with Realtek HD Audio Driver Officially Released by HP (audio driver version 6.0.9484.1)", "code_info": "Audio Driver Version: 6.0.9484.1. UDI-DI: 06936415972417. HP Pro Mini 400 G9 Desktop PC. Realtek HD Audio Driver Released by HP.\n\n1. WS host package (mini PC). Part Number 115-050935-00. Quantity 902\n\n2. Exch, Benevision Mini PC Workstation. Part Number E115-050935-00. Quantity 4", "firm_fei_number": "2221819", "recalling_firm": "Mindray DS USA, Inc. dba Mindray North America", "address_1": "800 Macarthur Blvd", "city": "Mahwah", "state": "NJ", "postal_code": "07430-2001", "additional_info_contact": "James Clifford\n+1-201-9958407", "reason_for_recall": "When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing.", "root_cause_description": "Software design", "action": "Mindray notified consignees of the recall on about 11/18/2025 via certified mail. Consignees were informed that they may continue to use the Central Monitoring System. If the HP Pro Mini 400 G9 Desktop PC used by the WS experiences the audio failure or screen freezes, restart the HP Pro Mini 400 G9 Desktop PC. Consignees were instructed to ensure applicable clinical staff are aware of the issue and letter and shared with any customer if further distributed. Consignees were also asked to complete and return the Acknowledgement and Receipt form provided. Mindray will provide a patch update for the audio driver of the affected HP Pro Mini 400 G9 Desktop PCs located at each facility and is anticipated to take approximately 10-15 minutes per HP Pro Mini 400 G9 Desktop PC. A representative from Mindray's Care team will contact consignees to schedule the update.", "product_quantity": "906 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the country of Canada.", "openfda": { "k_number": [ "K052854", "K013246", "K062278", "K013156", "K080192", "K253654", "K132036", "K974567", "K190073", "K100376", "K212622", "K102757", "K160862", "K193391", "K180430", "K091176", "K222550", "K012005", "K972880", "K971868", "K003998", "K223567", "K011999", "K020524", "K042771", "K013387", "K112282", "K121712", "K213863", "K140852", "K051634", "K020018", "K962473", "K042845", "K973640", "K121865", "K102974", "K103634", "K211949", "K973318", "K000647", "K210133", "K051283", "K974101", "K153156", "K151006", "K261367", "K020661", "K242728", "K142935", "K183238", "K151672", "K193043", "K030615", "K130707", "K992749", "K071047", "K012171", "K141756", "K121885", "K173203", "K182543", "K112650", "K161164", "K231506", "K203579", "K193421", "K243270", "K192952", "K061932", "K040945", "K202497", "K012531", "K060254", "K022507", "K001972", "K071391", "K182637", "K110521", "K260211", "K033281", "K061428", "K162607", "K023497", "K052972", "K032582", "K971683", "K010912", "K180566", "K241397", "K112047", "K032346", "K233418", "K191272", "K982342", "K990378", "K971569", "K033078", "K220058", "K070421", "K171322", "K061994", "K093925", "K992848", "K232548", "K994430", "K070204", "K130339", "K973527", "K111215", "K052975", "K211046", "K150632", "K143057", "K111296", "K242750", "K233834", "K210160", "K242842" ], "registration_number": [ "3015158050", "3014856521", "", "3006104191", "2080783", "2183613", "3010698831", "3009077524", "1000122786", "3013596024", "3008855170", "3008729547", "3012359877", "3012528160", "3015437214", "3009973336", "3009595635", "3013783488", "9611252", "3011696573", "3013546957", "3038761440", "3010157426", "3008058135", "3044754336", "8020045", "2032233", "3000976525", "3001104093", "1831750", "3007603826", "3004906872", "3013501110", "9681377", "3005783425", "3019388613", "3016595211", "3009499478", "3001570235", "3003971136", "9611500", "3011353843", "3007481893", "3016701404", "3016670256", "1824206", "3013896610", "3000126629", "3016852448", "3009156722", "3016618143", "3010703925", "3018188848", "1316463", "3009673645", "3004091281", "3007413079", "3009443693", "3015529350", "3011166598", "3014541700", "9610816", "1651104", "3003263092", "9610105", "3015134004", "3013500228", "3006240053", "2221819", "9680215", "3009831876", "1218950", "3015173634", "3008952681", "3004526608", "3027510187" ], "fei_number": [ "3015158050", "3014856521", "", "3002737156", "3006104191", "2080783", "2183613", "3010698831", "3009077524", "1000122786", "3013596024", "3008855170", "3003142870", "3008729547", "3012359877", "3012528160", "3015437214", "3009973336", "3009595635", "3013783488", "3011696573", "3013546957", "3002806783", "3038761440", "3010157426", "3008058135", "3044754336", "1000300598", "3006254866", "3023530182", "3002807720", "3000976525", "1831750", "3001104093", "3007603826", "3004906872", "3013501110", "3005783425", "3019388613", "3016595211", "3009499478", "3001570235", "3003971136", "3001084824", "3011353843", "3007481893", "3016701404", "3016670256", "1824206", "3013896610", "6736", "3000126629", "3016852448", "3009156722", "3016618143", "3010703925", "3018188848", "1316463", "3009673645", "3007413079", "3009443693", "3015529350", "3011166598", "3014541700", "3003263092", "3015134004", "2221819", "3013500228", "3006240053", "1218950", "3009831876", "3015173634", "3008952681", "3004526608", "3027510187", "3002807167" ], "device_name": "System, Network And Communication, Physiological Monitors", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.2300", "device_class": "2" } } ] }