{ "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": "2026-10-01", "results": { "skip": 0, "limit": 1, "total": 7 } }, "results": [ { "cfres_id": "222001", "product_res_number": "Z-3319-2026", "event_date_initiated": "2026-08-18", "event_date_posted": "2026-09-28", "recall_status": "Open, Classified", "res_event_number": "99617", "product_code": "NHJ", "product_description": "Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065; Phasitron 5 Breathing Circuit with Unified Connector, Product Number: P5-UC, used with In-Line Valve Instruction Manual", "code_info": "Product Number/UDI-DI: \nS00065/00849436000679, 00849436000709;\nP5-UC/00849436000686\nIn-Line Valve Instruction Manual: P20174 Rev D", "firm_fei_number": "1000524541", "recalling_firm": "Percussionaire Corporation", "address_1": "130 Mcghee Rd Ste 109 130 Mcghee Rd", "address_2": "Ste 109", "city": "Sandpoint", "state": "ID", "postal_code": "83864-8409", "additional_info_contact": "Benoit Ellenrieder\n208-263-2549", "reason_for_recall": "Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure, awareness during anesthesia, oversedation", "root_cause_description": "Device Design", "action": "On 8/18/2026, correction notices were emailed to customers and distributors who were informed of the following:\n\nThe following warning will be added to associated Instructions for Use:\nWarning: Do not use IPV therapy in conjunction with volatile anesthetic delivery systems. The high-frequency percussive flow generated during IPV therapy may alter the controlled delivery of volatile anesthetic agents within the breathing circuit, resulting in unpredictable anesthetic agent concentrations that may result in serious patient harm.\n\nNote: Consult the anesthesia healthcare provider before disconnecting from the system if considering delivering IPV directly to the patient's airway.\n\nCustomers were asked to do the following:\n1) Print and post the new warning for applicable IPV devices throughout your facility to ensure adequate distribution of new information to users.\n2) Reinforce adherence to the IPV User Guide and IPV Quick Reference Guide instructions, including ensuring communication and training primary users of IPV therapy, specifically those using it in-line with a ventilator, on the instructions and new warning.\n\nDistributors were asked to do the following:\n- Translate (if applicable) and send the Urgent Medical Device Field Safety Notice to affected end customers.\n-If the Distributor receives the signed acknowledgement letters from affected customers, please forward them and all related communication to FSCA@sentec.com.\n\nIf there are any additional questions related to the updated instructions or other questions, please contact FSCA@sentec.com", "product_quantity": "61,858", "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of CA, PA, OK, GA, TX, OH, WI, WA, NY, MO, FL, DE, LA, SC, WV, NJ, NE, KS, NC, AL, CO, VA, OR, AZ, IL, CT, ID, NH, UT, TN, MD, VT, MS, NV, DC, ME, IA, AR, HI, ND, IN, MT, NM, MN, MI, SD, MA, AK, RI and the countries of Canada, Belgium, Chile, France, Germany, Israel, Italy, Latvia, Netherlands, Norway, Oman, Philippines, Portugal, Qatar, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Kuwait, Australia, South Africa.", "openfda": { "k_number": [ "K192143", "K121955", "K260604", "K981726", "K151689", "K002598", "K213564", "K113549", "K140605", "K242438", "K982016", "K051964", "K191912", "K253001", "K124032", "K924174", "K132988", "K072292", "K140598", "K200988", "K120277", "K003684", "K905236", "K895485", "K781232", "K231728" ], "device_name": "Device, Positive Pressure Breathing, Intermittent", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5905", "device_class": "2", "registration_number": [ "3000126629", "3017520736", "3029227324", "3007123976", "3006240053", "3008145987", "3003589956", "3029845", "3020562909", "3021244152", "3008700378", "2951529", "3006446479", "3010817335", "3006087789", "3018783526", "3016774528", "3004050971", "9617566", "1000604079", "2518422", "3011120183", "3006534321", "3023272766", "3017373426", "2183816", "3010834934", "3013095415", "3009987158" ], "fei_number": [ "3000126629", "3017520736", "3029227324", "3007123976", "3006240053", "1000307109", "1000524541", "3008145987", "3003589956", "3020562909", "3021244152", "3008700378", "3006446479", "3010817335", "3003244771", "3006087789", "3018783526", "3016774528", "3004050971", "2518422", "1000604079", "3011120183", "3006534321", "3023272766", "3017373426", "2183816", "3010834934", "3013095415", "3009987158" ] } } ] }