{ "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": "176681", "product_res_number": "Z-0258-2020", "event_date_initiated": "2019-09-13", "event_date_posted": "2019-10-31", "recall_status": "Open, Classified", "res_event_number": "83889", "product_code": "MHX", "k_numbers": [ "K093788", "K113798" ], "product_description": "The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372.", "code_info": "Software version VG4.1.1/VG4.0.3 and lower", "firm_fei_number": "3005783425", "recalling_firm": "Draegar Medical Systems, Inc.", "address_1": "6 Tech Dr", "city": "Andover", "state": "MA", "postal_code": "01810-2434", "additional_info_contact": "Mike Kelhart\n215-660-2349", "reason_for_recall": "Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network.", "root_cause_description": "Software design", "action": "On September 13, 2019, the firm distributed Urgent Medical Device Recall letters to customers. Customers were informed of the cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDOS) (packet storm), Spoofing, and Tampering.\n\nTo mitigate the cybersecurity concerns, Draeger will be releasing software version VG4.2 for both the Cockpit and the M540, which will correct these cybersecurity vulnerabilities. The software is expected to be released for distribution in December 2019. Upgrades of the IACS systems will commence in January 2020. \n\nWhile the firm is in the process of updating the software, customers are asked to limit access to the Infinity Network by following these security recommendations:\n\n1. Physical security of the patient monitors is recommended and is the responsibility of the\noperating organization.\n2. Physical security of the telecommunications closet is recommended and is the responsibility\nof the operating organization.\n3. Draeger recommends that operating organizations restrict physical access to unused Ethernet\nports on the IACS.\n4. Draeger recommends that operating organizations restrict physical access to unused USB and\nserial ports on the IACS.\n5. Draeger relies on the medical device isolation mechanism of the VLANs and the proper\nconfiguration, implementation, and use of the operating organization's security measures to\nprevent the introduction of malware onto the Infinity Network.\n\nYour local Draeger Service Representative will contact you to schedule an appointment to upgrade your system(s) software free of charge once the new software version is released for distribution. \n\nIf you have any questions regarding this letter, please contact Michael Kelhart between the hours of\n8:00 AM - 4:30 PM EST at 1-800-437-2437 (press 1 at the prompt, then 32349).", "product_quantity": "5634", "distribution_pattern": "US Nationwide distribution.", "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", "K100939", 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