Ventec Life Systems VOCSN Multi-Function Ventilator… — Class II medical device recall Z-1902-2021
Ongoing recall by Ventec Life Systems, Inc., reported 2021-06-30, distributed nationwide. Due to a component failure, ventilators may unexpectedly shut down or have a loss of blower function while in
| Recall number | Z-1902-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ventec Life Systems, Inc., Bothell, WA, United States |
| Recall initiated | 2021-05-10 |
| Classified | 2021-06-21 |
| Reported by FDA | 2021-06-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | HK, JP |
| UPC / GTIN / UDI-DI | 00855573007006, 00855573007204, 00855573007433, 00855573007730, 00855573007747, 00855573007761, 00855573007778, 00855573007785, 00855573007792 |
| Serial numbers | 110392, 112765, 112766, 112767, 112768, 112770, 112774, 112775, 112776, 112778, 112779, 112780, 112787, 112792, 112798, 112807, 112814, 112815, 112821, 112822, 112823, 112824, 112825, 112826, 112829 and 390 more |
| Model numbers | PRT-00490-001, PRT-00490-100, PRT-00900-001, PRT-00900-100, PRT-01098-000, PRT-01100-000, PRT-01100-001 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1902-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.