{ "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": "2026-04-01", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Ongoing", "city": "Bothell", "state": "WA", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "87838", "recalling_firm": "Ventec Life Systems, Inc.", "address_1": "22002 26th Ave Se", "address_2": "N/A", "postal_code": "98021-4903", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "Distribution US nationwide, Hong Kong, and Japan", "recall_number": "Z-1902-2021", "product_description": "Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;", "product_quantity": "1,934 devices (415 device that have not been updated)", "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.", "recall_initiation_date": "20210510", "center_classification_date": "20210621", "report_date": "20210630", "code_info": "Catalog Number: PRT-00490-001 GTIN (Primary ID): 00855573007792/00855573007006 Serial Numbers: 114303; 114304; 113728; 113729; 113697; 114296; 113587; 113684; 113706; 113003; 112957; 112961; 112962; 112965; 112972; 112974; 112994; 112995; 112999; 113006; 113008; 113010; 113520; 113522; 113525; 113533; 113534; 113536; 113547; 113550; 113555; 113556; 113557; 113561; 113563; 113689; 113724; 114021; 114101; 114105; 114106; 114107; 114109; 114110; 114111; 114116; 114117; 114310; 114333; 114108; 112792; 112798; 114497; 114324; 114325; 114330; 114336; 114493; 114537; 113046; 113662; 113667; 113682; 113591; 113594; 113654; 113655; 113740; 114020; 114030; 114044; 114046; 114048; 114096; 114114; 114019; 114025; 114027; 114033; 114039; 114040; 114045; 114051; 114028; 113704; 113746; 113748; 113753; 113760; 113061; 113725; 113586; 113691; 114307; 114309; 113028; 113066; 113539; 113515; 113709; 114047; 112814; 112824; 112829; 112830; 112844; 112848; 112865; 112866; 112807; 112822; 112823; 112834; 112835; 112847; 112854; 112876; 122848; 113758; 114508; 114951; 114342; 114343; 114346; 114351; 114360; 114500; 114345; 114499; 114505; 112976; 113037; 113040; 113524; 114322; 114498; 114510; 114636; 114640; 114641; 114676; 114685; 114695; 114701; 114820; 114827; 114841; 114900; 114901; 114674; 114725; 114800; 114810; 114812; 114822; 114825; 113057; 113063; 112821; 112839; 112842; 112867; 112826; 112837; 112825; 112982; 112987; 113510; 113511; 113546; 113584; 113592; 113652; 113686; 113710; 113723; 113756; 113671; 113675; 113715; 114009; 114013; 114489; 114494; 113549; 113744; 114637; 114947; 112765; 112766; 112767; 112768; 112770; 112774; 112775; 112776; 112778; 112779; 112780; 112787; 112815; 112841; 112862; 112968; 112977; 113013; 113014; 113016; 113017; 113018; 113027; 113032; 113039; 113050; 113535; 113562; 113588; 113658; 113755; 114032; 114488; 114842; AARC0001; AARC002; AARC003; AARC004; AARC005; AARC006; AARC007; AARC008; AARC009; 114095; 113590; Catalog 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 Numbers: 114444; 114451; 114615; 114226; 114442; 114450; 114452; 114441; 114453; Catalog Number: PRT-01100-000 GTIN (Primary ID): 00855573007747 Serial Numbers: 114556; 114591; 114634; 114771; 114779; 114603; 114606; 114667; 114710; 114713; 114737; 114739; 114559; 114783; 114869; 114576; 114587; 114364; 114369; 114374; 114387; 114391; 114560; 114568; 114764; 114776; 114787; 114849; 114549; 114569; 114705; 114562; 114355; 114372; 114405; 114550; 114594; 114601; 114652; 114659; 114661; 114662; 114358; 114383; 114386; 114389; 114390; 114530; 114540; 114401; 114422; 114424; 114548; 114670; 114714; 114850; 114414; 114417; 114554; 114561; 114861; 114862; 114543; 114786; 114789; 114912; 114917; 114851; 114628; 114211; 114542; 114528; 114531; 114483; 114750; 114643; 114644; 114748; 114926; 114991; 114891; 114892; 114894; 114357; 114409; 114604; 114413; 114653; 114654; 114734; 114754; Catalog Number: PRT-01100-001 GTIN (Primary ID): 00855573007747 Serial Numbers: 114965; 114966; 114967;" } ] }