{ "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": "177026", "product_res_number": "Z-0372-2020", "event_date_initiated": "2019-10-09", "event_date_created": "2019-11-14", "recall_status": "Open, Classified", "res_event_number": "84028", "product_code": "MHX", "k_numbers": [ "K130711" ], "product_description": "Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301", "code_info": "All systems using Software version VG2.3.1 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": "The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDoS), Spoofing, and Tampering.", "root_cause_description": "Software design", "action": "An Urgent Medical Device Recall notification letter dated 10/9/19 was sent to customers. \n\nRecommended cybersecurity precautions:\nWhile we are in the process of updating the software, we recommend that you follow best recommended practices to limit access to the devices and wireless network:\n\" Physical security of the patient monitors is recommended and is the responsibility of the operating organization.\n\" Physical security boundaries to prevent access to your facility's network infrastructure is recommended and is the responsibility of the operating organization.\n\" Drager relies on the medical device isolation mechanism of the VLANs and the proper configuration, implementation, and use of the operating organization's security measures to prevent the introduction of malware onto the Infinity Network.\n\nAction required:\nPlease complete the attached Acknowledgement and Response Form and return it to Drager per instructions included on the form. The software upgrade will be provided free of charge. The upgrade path for your M300 device is dependent on the part number of your M300s currently in use. Your local Drager representative will contact you prior to the availability of software version VG2.3.2 to discuss the upgrade path.\n\nIf you have any questions regarding this letter, please contact Michael Kelhart between the hours of 8:00 AM - 4:30 PM EST at 1-800-437-2437 (press 1 at the prompt, then 32349).", "product_quantity": "12204", "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", "K252589", "K153160", "K050141", "K070588", "K150975", "K250349", "K170876", "K033694", "K942700", "K030431", "K030105", "K082045", "K061675", "K030038", "K220989", "K062576", "K151063", "K043549", "K250453", "K123074", "K011093", "K981576", "K240320", "K062283", "K251146", "K112803", "K152407", "K945385", 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