{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "167424", "product_res_number": "Z-0170-2019", "event_date_initiated": "2018-08-30", "event_date_created": "2018-10-17", "recall_status": "Terminated", "event_date_terminated": "2018-12-20", "res_event_number": "81084", "product_code": "MHX", "k_numbers": [ "K162607" ], "product_description": "Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00", "code_info": "This potential issue affects BeneVision DMS with software version 03.01.00 to 03.03.00", "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": "Ms. Diane Arpino\n201-995-8407", "reason_for_recall": "The firm has identified performance anomalies with the device caused when more than 64 TD60 telemetry transmitters have been connected to a central station. The anomaly causes some ECG waveforms to appear as a flat line at the centralized viewing station and will manifest if more than 64 TD60 transmitters have been connected to a given central station server. Each central station supports only 32 transmitters at a time. For the issue to manifest, the BeneVision DMS needs to be configured to use flexible device assignment, have more than 64 TD60 transmitters, and the workflow must allow 64 TD60s to move around\nbetween multiple central stations in the same care area.", "root_cause_description": "Software design", "action": "The firm notified affected consignees on August 30, 2018, via Urgent Medical Device Recall letter. The letter advised customers of the software issue when more than 64 telemetry transmitters have been connected to a central station.\n\nCustomers were advised to use the system normally, but informed that a Mindray Service Representative would be in contact to arrange for a system software update to be performed at the customer site.\n\nMindrays Technical Support team may be reached at (877) 913-9663 (Option 1), Monday\nthrough Friday, 8:30am - 5:30pm ET should you have technical questions.\n\nCustomers were also asked to complete and return an attached Acknowledgement and Receipt Form.", "product_quantity": "5", "distribution_pattern": "Distributed to accounts in CA, CO, FL, MA, NY, PA, PR, TX, and WV.", "openfda": { "k_number": [ "K014213", "K992273", "K062098", "K050742", "K152902", "K023698", "K173036", "K092369", "K081793", "K043551", "K123472", "K024108", "K130584", "K113657", "K192514", "K221904", "K923054", "K023674", "K033492", "K031320", "K043439", "K022834", "K033444", 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