{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "167618", "product_res_number": "Z-0497-2019", "event_date_initiated": "2018-09-18", "event_date_posted": "2018-12-18", "recall_status": "Terminated", "event_date_terminated": "2021-02-01", "res_event_number": "81167", "product_code": "CBK", "k_numbers": [ "K162738" ], "product_description": "Puritan Bennett 980 (PB980) ventilator series:\nPuritan Bennett\" 980 Pediatric Adult Ventilator\nPuritan Bennett\" 980 Neonatal Ventilator\nPuritan Bennett\" 980 Universal Ventilator\n\nProduct Usage:\nThe Puritan Bennett 980 Series Ventilator is designed for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb). It is suitable for service in hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilatory support using medical oxygen and compressed medical air from either an internal air compressor or external air sources to deliver oxygen concentrations of 21% to 100%. Ventilatory support can be delivered invasively or non-invasively, to patients who require the followingtypes of ventilator support: Positive Pressure Ventilation, delivered invasively (via endotracheal tube or trach tube) or non-invasively (via mask or nasal prongs). Assist/ Control, SIMV or Spontaneous modes of ventilation", "code_info": "Serial Numbers: 35B1300001 through 35B1300051  35B1400003 through 35B1402216   35B1500001 through 35B1502227  35B1600001 through 35B1601408  35B1700001 through 35B1702519  35B1800001 through 35B1801541  35B1400001  35B1601182, 35B1601183, 35B1601193, 35B1601197, 35B1601242 35B1601243, 35B1601245, 35B1702479, 35B1601001, 35B1601089", "firm_fei_number": "1282497", "recalling_firm": "COVIDIEN LLC", "address_1": "15 Hampshire St", "city": "Mansfield", "state": "MA", "postal_code": "02048-1113", "additional_info_contact": "SAME\n508-261-8000", "reason_for_recall": "Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) functionality and labeling of the scalar waveform displayed on GUI during ventilation", "root_cause_description": "Device Design", "action": "Medtronic notified U.S. consignees notified via Federal Express or certified mail on September 19, 2018, and the letter informs customers that Medtronic has developed a software update, Maintenance Release (MR) 5.4. Medtronic Service Engineers will load the MR5.4 software during the next scheduled or planned maintenance visit. \nImmediately notify all care environments in which the PB980 ventilators are used about this notification.\n\" If your facility has distributed PB980 ventilators to other persons or facilities, please promptly forward a copy of this letter to those recipients.\n\" Complete the attached form and return it as directed to confirm your receipt and understanding of this information.\nAny incidents related to this issue or if you have any questions, please contact our Technical Support Department immediately at 1-800-255-6774.\nOut--Side US accounts notified by Medtronic Regulatory Partners worldwide on 9/17/18 for translation in their respective country.", "product_quantity": "9,593", "distribution_pattern": "Worldwide Distribution - US Nationwide\nForeign:\nCanada\nArgentina\nChile\nJapan\nHong Kong\nTaiwan\nUruguay\nAustria\nAustria\nAzerbaijan\nBelgium\nBosnia And Herzegovina\nBulgaria\nCroatia\nCzech Republic\nFrance\nGermany\nGreece\nHungary\nIreland\nIsrael\nItaly\nKazakhstan\nKenya\nKuwait\nLatvia\nLebanon\nLithuania\nNetherlands\nOman\nPakistan\nPoland\nPortugal\nRomania\nRussian Federation\nSaudi Arabia\nSlovakia\nSlovenia\nSouth Africa\nSpain\nSweden\nSwitzerland\nTunisia\nTurkey\nUnited Arab Emirates\nIran\nUnited Kingdom", "openfda": { "k_number": [ "K111473", "K243767", "K820746", "K782074", "K810893", "K911336", "K060647", "K062019", "K141943", "K092148", "K081842", "K151814", "K924930", "K902405", "K072590", "K872482", "K853300", "K942938", "K911804", "K914424", "K902506", "K232365", "K842363", "K023366", "K820248", "K872466", "K800114", "K914607", "K941308", "K062093", "K843737", "K111595", "K812980", "K914485", "K180779", "K970165", "K201082", "K862025", "K112729", "K953238", "K023350", "K122560", "K051767", "K192307", "K821930", "K152068", "K813253", "K812642", "K121379", "K053388", "K052863", "K003068", "K870861", "K781160", 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