{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "170564", "product_res_number": "Z-0974-2019", "event_date_initiated": "2019-02-08", "event_date_created": "2019-03-05", "recall_status": "Open, Classified", "res_event_number": "82014", "product_code": "MHX", "k_numbers": [ "K152407" ], "product_description": "Infinity Delta Family patient monitors\n\nThe Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcp02, which for the neonatal population, is to only be used when the patient is not under gas anesthesia.-Omega and Omega S are intended to be used on adult, pediatric, and neonatal populations.", "code_info": "All software versions, all serial numbers.", "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": "Technical Support\n800-437-2437", "reason_for_recall": "The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose functionality, and/or lose communication.", "root_cause_description": "Software design", "action": "On February 8, 2019, the firm, Drager, notified affected customers of the recall via an \"Urgent: Medical Device Recall\" letter. Customers were informed that the existing software had cybersecurity vulnerabilities and that software version VF10.1 would mitigate these issues.\n\nCustomers were asked to complete a Customer Acknowledgment and Response Form and return it to Drager via fax 215-372-2940 or email to \nditelford.guality@draeger.com. Your local Draeger Service representative will contact you to schedule an appointment for upgrading your systems software once a compatible version has been released for distribution.\n\nIf you are aware of any incidents related to this issue or if you have any further questions regarding operation of your patient monitor, please contact Drager Service Technical Support between the hours of 8:00 AM- 8:00 PM EST at 1-800-437-2437 (press 2 at the prompt, then 2 again).", "product_quantity": "10699 in total", "distribution_pattern": "US Nationwide distribution including Puerto Rico.", "openfda": { "k_number": [ "K130849", "K081891", "K082045", "K220308", "K143676", "K150082", "K151860", "K132075", "K190011", "K011000", "K000815", "K022889", "K102040", "K033304", "K040395", "K223498", "K012915", "K251702", "K945385", "K073462", "K160981", "K132533", "K023569", "K173036", "K100939", "K081983", "K923054", "K000854", "K990563", "K010923", "K153275", "K113623", "K050141", "K183387", "K011918", 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