{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "104431", "product_res_number": "Z-0296-2012", "event_date_initiated": "2011-10-11", "event_date_posted": "2012-01-11", "recall_status": "Terminated", "event_date_terminated": "2012-11-06", "res_event_number": "60099", "product_code": "CBK", "k_numbers": [ "K083526" ], "product_description": "Trilogy 100, 200 and 202 Ventilators\n\nThe device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation.", "code_info": "Serial Numbers: GV111030238, GV111040533, GV111040627, GV111040632, GV111040640, GV111040651, GV111040652, GV111040653, TV011031510, TV011040511, TV011040516, TV011040518, TV011040524, TV011040529, TV011040530, TV011040601, TV011040602, TV011040609, TV011040615, TV109081805, TV109081806, TV109081807, TV111021835, TV111022551, TV0111022832, TV111030422, TV111030441, TV111030445, TV111030453, TV111030774, TV111030790, TV111030853, TV111030932, TV111030947, TV111030976, TV111030978, TV111031001, TV111031011, TV111031037, TV111031045, TV111031057, TV111031064, TV111031067, TV111031113, TV111031403, TV111031413, TV111031420, TV111031462, TV111031554, TV111032252, TV111032254, TV111032306, TV111032316, TV111032562, TV111032809, TV111032811, TV111032812, TV111032822, TV111032827, TV111032829, TV111032830, TV111032832, TV111032833, TV111032901, TV111032905, TV111032906, TV111032909, TV111032912, TV111032913, TV111032914, TV111032920, TV111032923, TV111032924, TV111032925, TV111032926, TV111032929, TV111032934, TV111032935, TV111032938, TV111032939, TV111032940, TV111033001, TV111033004, TV111033005, TV111033006, TV111033009, TV111033010, TV111033016, TV111033018, TV111033019, TV111040110, TV111040113, TV111040117, TV111040404, TV111040405, TV111040411, TV111040415, TV111040416, TV111040418, TV111040419, TV111040420, TV111040423, TV111040424, TV111040428, TV111040432, TV111040438, TV111040703, TV111040729, TV111040735, TV111040803, TV111040808, TV111040830, TV111041118, TV111041304, TV111041306, TV111041435, TV111041436, TV211032405, TV211032409, TV211032412, TV211032413, TV211032414, TV211032415, TV211032419, TV211032420, TV211032430, TV211032431", "firm_fei_number": "2518422", "recalling_firm": "Respironics, Inc.", "address_1": "1001 Murry Ridge Ln", "city": "Murrysville", "state": "PA", "postal_code": "15668-8517", "additional_info_contact": "Ralph Asencio\n724-387-7651", "reason_for_recall": "Trilogy 100, 200 and 202 units are being recalled due to low impeller press-force used during the manufacturing process. If the press force were low enough, theoretically the impeller could move up the shaft and come into contact with the inside of the blower housing/impeller enclosure. This may impact therapy.", "root_cause_description": "Process design", "action": "Philips Healthcare, began notifying customers via telephone on October 11, 2011. The telephone notification discussed the product, problem and actions to be taken. The customers were instructed to not remove a ventilator from a patient without providing a replacement unit; provide a fax number or email address Philips can use to send the Business Reply Form to complete and return via fax to: 800-733-9962 or email: report.request@philips.com; locate their affected devices (if the device is with a patient, replace it with a non-affected unit-Philips will provide a loaner overnight if needed)-(if the device is in their inventory, quarantine it and return it using the RA number provided in the email/fax that Philips sends them); and If loaner units are needed, they are to call 1-877-387-3311 to arrange return of your affected device and to obtain a loaner unit.\n\nIf you have any questions or concerns, contact Philips Respironics at 877-387-3311.", "product_quantity": "127", "distribution_pattern": "Worldwide distribution: USA (nationwide) including states of: AZ, CA, CO, GA, ID, IL, KS, MI, MO, NE, NV, NJ, OH, PA, TN, and TX; and countries of: Australia, Austria, Canada, China, Denmark, Germany, Great Britain, India, Italy, Japan, Korea (Republic of [South] Korea), Netherlands, Philippines, Saudi Arabia, Spain (Espana), and Turkey.", "openfda": { "k_number": [ "K960168", "K953238", "K193056", "K052554", "K081743", "K111595", "K943412", "K982132", "K864379", "K981971", "K812953", "K051262", "K082351", "K241135", "K980642", "K151814", "K072412", "K081837", "K240807", "K061627", "K123149", "K874371", "K070513", "K053502", "K012693", "K040221", "K981412", "K981072", "K895779", "K013642", "K913423", "K833786", "K974176", "K781926", "K893043", "K790199", "K913972", "K062710", "K010608", "K202970", "K152068", "K881420", "K882764", "K822103", "K842876", "K905235", "K921387", "K002686", "K841818", "K832700", "K241520", "K854300", "K844350", "K864129", "K820248", "K915488", "K083050", "K870275", "K062267", "K822233", "K023350", "K092135", "K871448", "K082966", "K120726", "K130178", "K860798", "K896269", "K972248", "K213098", 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