Ventec Life Systems, Inc. Recall 87838
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;
Ventec Life Systems, Inc. Recall 87838 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1902-2021 |
| Event ID | 87838 |
| Event 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 Type | Devices |
| Distribution | Distribution US nationwide, Hong Kong, and Japan |
| Quantity | 1,934 devices (415 device that have not been updated) |
| Recall Reason | 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. |
| Device Classification | 20210630 |
| Device 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; |
| Center Classification Date | 20210621 |
| Recall Initiation Date | 20210510 |
| Recalling Firm | Ventec Life Systems, Inc. |
| Initial Notification | Letter |
| Similar To |