{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "187222", "product_res_number": "Z-1902-2021", "event_date_initiated": "2021-05-10", "event_date_posted": "2021-06-21", "recall_status": "Open, Classified", "res_event_number": "87838", "product_code": "CBK", "k_numbers": [ "K162877" ], "product_description": "Ventec Life Systems VOCSN Multi-Function Ventilator\n\nModel/Version/Catalog Number:\nV+O+C+S+N+Pro/English/PRT-00490-001;\nV+O+C+S+N+Pro/Japan/PRT-00490-100;\nV+C+Pro/English/PRT-00900-001;\nV+C+Pro/Japan/PRT-00900-100;\nV+C/English/PRT-01098-000;\nV+O+C+S+N/English/PRT-01100-000;\nV+O+C+S+N/English/PRT-01100-001;", "code_info": "Catalog Number: PRT-00490-001 GTIN (Primary ID): 00855573007792/00855573007006 Serial 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Number: PRT-00490-100 GTIN (Primary ID): 00855573007761/00855573007204 Serial Numbers: 112929; 113598; 113233; 113238; 113239; 113241; 113243; 113244; 113245; 113603; 114193; 114201; 114255; 114266;  Catalog Number: PRT-00900-001 GTIN (Primary ID): 00855573007778/00855573007433 Serial Numbers: 113365; 113405; 113906; 113962; 113407; 113414; 113430; 113390; 113437; 113262; 113380; 113458; 113384; 113398; 113442; 113858; 113441; 113443; 113445; 113915; 113817; 113898; 113899; 113378; 113395; 113923; 113972; 113937; 113945; 113957; 113961; 113968; 113368; 113373; 113379; 113264; 113351; 113389; 113370; 113377; 113454; 113468; 113804; 113823; 113830; 113837; 113838; 113881; 113882; 113888; 113892; 113902; 113927; 113967; 113399;  Catalog Number: PRT-00900-100 GTIN (Primary ID): 00855573007785 Serial Numbers: 113096; 113300; 112923; 113107; 112877; 110392; 113143; 113183; 113274; 113323;  Catalog Number: PRT-01098-000 GTIN (Primary ID): 00855573007730 Serial 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"firm_fei_number": "3013095415", "recalling_firm": "Ventec Life Systems, Inc.", "address_1": "22002 26th Ave Se", "city": "Bothell", "state": "WA", "postal_code": "98021-4903", "additional_info_contact": "Mark SooHoo\n425-686-1765", "reason_for_recall": "Due to a component failure, ventilators may unexpectedly shut down or have a loss of blower function while in patient use. The shutdown potentially prevents the ventilator from providing ventilation therapy.", "root_cause_description": "Device Design", "action": "During the week of May 10, 2021, the firm sent an URGENT: MEDICAL DEVICE RECALL NOTIFICATION letter via FedEx or overnight mail to customers informing them that due to malfunctions of the Control Board there is the potential of unexpected shut downs and/or lost of ventilator blower function. As a result, the ventilators may fail to provide ventilation therapy to the patients.\n\nCustomers are instructed to complete the following clinical action until a replacement unit can be provided:\nFollow your procedures to transfer the patient to an alternative source of ventilation, if available. If\nno other ventilation method is available, you may continue to use the affected product adhering to\nthe guidelines below:\n1. Use only when the patient is actively monitored to ensure timely response to a potential malfunction.\n2. Operate the ventilator as defined in the Instructions for Use and promptly respond to all alarms activated by the ventilator.\n3. Use an external SpO2 monitor and set the alarm thresholds appropriately if the patient is oxygen dependent.\n4. Connect the ventilator to an external monitoring system, wherever possible.\n\nIn addition, Customers are to acknowledge receipt of the Customer Notification Letter by:\n1. Confirm receipt of this notification letter by returning the enclosed Customer Response Form to Ventec within 7 days.\n2. Upon receipt of the Customer Response Form, Ventec will arrange shipment of replacement device(s) or arrange repair of existing device(s).\n3. Return the affected product to Ventec per instructions and shipping label provided with replacement device(s). Contact Ventec Customer Support at 844-MYVOCSN (844-698-6276) to discuss alternative arrangements, if necessary.\n\nIf customers are no longer the owner of any of these devices, they need to complete an ownership transfer form at VentecLife.com/tracking so that the Recalling Firm can follow up with the current owner of the impacted device(s).\n\nIf customers have any question", "product_quantity": "1,934 devices (415 device that have not been updated)", "distribution_pattern": "Distribution US nationwide, Hong Kong, and Japan", "openfda": { "k_number": [ "K896381", "K021573", "K915312", "K063806", "K853760", "K040642", "K843424", "K897113", "K864431", "K123149", "K003770", "K841818", "K253647", "K213098", "K051263", "K992133", "K812958", "K032226", "K120574", "K040221", "K913972", "K871433", "K860438", "K070899", "K842688", "K926292", "K012691", "K901953", "K010925", "K103318", "K921726", "K130171", "K072590", "K812016", "K222644", "K053270", "K864129", "K905272", "K923992", "K121379", 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