Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+P...
FDA Device Recall #Z-1902-2021 — Class II — May 10, 2021
Recall Summary
| Recall Number | Z-1902-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 10, 2021 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Ventec Life Systems, Inc. |
| Location | Bothell, WA |
| Product Type | Devices |
| Quantity | 1,934 devices (415 device that have not been updated) |
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;
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.
Distribution Pattern
Distribution US nationwide, Hong Kong, and Japan
Lot / Code Information
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;
Other Recalls from Ventec Life Systems, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1196-2025 | Class I | VOCSN Multi-Function Ventilators: VOCSN+Pro (V... | Feb 3, 2025 |
| Z-1070-2024 | Class I | VOCSN Patient Breathing Package (Pediatric, Act... | Jan 9, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.