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Ventec Life Systems, Inc. recalls Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-00
Recalled June 30, 2021 · FDA recall Z-1902-2021 · Ventec Life Systems
Hazard
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. · FDA Class II
Units
1,934 devices (415 device that have not been updated)
Sold at
Distribution US nationwide, Hong Kong, and Japan
Description
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.
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;
Manufacturer(s)
Ventec Life Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →