{ "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": "114367", "product_res_number": "Z-0630-2013", "event_date_initiated": "2011-05-12", "event_date_posted": "2013-01-03", "recall_status": "Terminated", "event_date_terminated": "2013-02-19", "res_event_number": "63616", "product_code": "MSX", "k_numbers": [ "K080192" ], "product_description": "DPM Central Station\nMindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430\n\nThe Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.", "code_info": "510 K K080192 P/N 300BF-PA200002", "firm_fei_number": "2221819", "recalling_firm": "Mindray DS USA, Inc. d.b.a. Mindray North America", "address_1": "800 MacArthur Blvd.", "city": "Mahwah", "state": "NJ", "postal_code": "07430", "additional_info_contact": "Ms. Diane Arpino\n201-995-8407", "reason_for_recall": "There is a software anomaly with the DPM Central Monitoring System where the trend data of one patient maybe replaced with the trend data of a second patient.", "root_cause_description": "Software design", "action": "Mindray sent a Product Corrective Action letter dated May 12, 2012, to all affected customers via certified mail return receipt requested to two medical facilities. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that the issue would be corrected through a softweare upgrade of the affected product. A Mindray Service Representative would contact their facility to arrange for the software upgrade at no cost to them.\nFor questions regarding this recall call 1-800-288-2121.", "product_quantity": "two units", "distribution_pattern": "Nationwide Distribution including OH and GA", "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" } } ] }