FDA Device recall Z-1902-2021
Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001
- FDA Device
- Class II
- ongoing
- Published 2021-06-30
On 2021-06-30 the FDA classified a Class II recall of Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001 by Ventec Life Systems, citing 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 pr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1902-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-05-10 |
| Published | 2021-06-30 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ventec Life Systems |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | Catalog Number: PRT-00490-001 GTIN (Primary ID): 00855573007792/00855573007006 Serial Numbers: 114303; 114304; 113…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; 11 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1902-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.