{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "187798", "product_res_number": "Z-1972-2021", "event_date_initiated": "2021-06-14", "event_date_posted": "2021-07-13", "recall_status": "Open, Classified", "res_event_number": "88058", "product_code": "MNS", "product_description": "Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use; Product Numbers DSX9999H11, INX9999H19, RINX9999H19\n\n The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It is specifically for the care of adult and pediatric patients >7 years of age and >18kgs.", "code_info": "All Serial Numbers  Material Numbers: DSX9999H11 INX9999H19 RINX9999H19", "firm_fei_number": "2518422", "recalling_firm": "Philips Respironics, Inc.", "address_1": "1001 Murry Ridge Ln", "city": "Murrysville", "state": "PA", "postal_code": "15668-8517", "reason_for_recall": "The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.", "root_cause_description": "Device Design", "action": "Urgent Medical Device Recall notification letters were sent to customers beginning on 6/14/21.\n\nImmediate Actions to be taken by You, the User:\n1. Discontinue use of your device and work with your physician or Durable Medical Equipment (DME) provider to determine the most appropriate options for continued treatment. \n2. Register your device on the recall website www.philips.com/src-updates\n Call 1-877-907-7508 if you cannot visit the website or do not have internet access.\n\n\nAn updated URGENT: Medical Device Recall notification letter was issued on 11/16/21.\n\nImmediate Actions to be taken by You, the User:\n1. Talk to your health care provider to decide on a suitable treatment for your condition, which may include:\na. Stopping use of your device\nb. Continuing to use your affected device, if your hcpr determines that the benefits outweigh the risks identified in the recall notification.\nc. Using another similar device that is not part of the recall or using alternative treatments for sleep apnea.\n2. Follow the manufacturers instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. Ozone cleaners may exacerbate the breakdown of the foam, and there are other potential risks associated with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories.\n3. Report any problems with a device through the FDA MedWatch Voluntary Reporting Form.\n4. Register your device on the recall website www.philips.com/src-update\nwith your device Serial Number.\nc. Call 1-877-907-7508 if you cannot visit the website or do not have internet access.\nDevices should be serviced only by qualified technicians. They do not include user serviceable parts. Attempts to remove the sound abatement foam may render the device permanently inoperative. Devices damaged due to attempts by the user to remove the sound abatement foam will not be able to be remediated.", "product_quantity": "15,357,775 (10,307,186 in US, 5,039,748 OUS) in total", "distribution_pattern": "Global distribution", "openfda": { "k_number": [ "K092043", "K071509", "K093731", "K031896", "K012323", "K122324", "K090248", "K942210", "K123557", "K031656", "K240778", "K252078", "K113053", "K102465", "K231064", "K962517", "K112914", "K171827", "K213169", "K093070", "K070328", "K101130", "K992530", "K092818", "K092186", "K020777", "K984407", "K060105", "K161492", "K113714", "K974417", "K051364", "K053168", "K251889", "K063533", "K113815", "K111378", "K153061", "K060546", "K090539", "K033276", "K113288", "K132371", "K063540", "K251661", "K123511", "K161487" ], "device_name": "Ventilator, Continuous, Non-Life-Supporting", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5895", "device_class": "2", "registration_number": [ "3011205710", "3013075752", "3033526676", "2518422", "3018783526", "3033530343", "3023272766", "3007220521", "3002797442", "3038562397", "3011120183", "3008566132", "8040510", "9617566", "3012428212", "3007573469", "3023322457", "3010817335", "3009096682", "3029227324", "3004604967", "9680721", "3000126629", "3013154126", "3004802249", "3012305175", "3013505405", "3007421149", "3004748541", "3017684630", "3001400310", "3026086583", "3042507287" ], "fei_number": [ "3011205710", "3013075752", "3033526676", "2518422", "3018783526", "3033530343", "3023272766", "3007220521", "3002797442", "3038562397", "1000115734", "3011120183", "3008566132", "3012428212", "3001319476", "3023322457", "3010817335", "3009096682", "3029227324", "3004604967", "3000126629", "3013154126", "3004802249", "3012305175", "3013505405", "3007421149", "3004748541", "3017684630", "3003244771", "3001400310", "3026086583", "1000244733", "3042507287" ] } } ] }