Ventec VOCSN Ventilators May Shut Down Due to Component Failure
Ventec VOCSN ventilators may unexpectedly shut down or lose blower function during patient use due to component failure. This could prevent the device from providing ventilation therapy. About 1,934 devices are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries documented in the source text. The hazard—unexpected loss of function in a critical life-support device—meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Ventec Life Systems, Inc. has issued a recall of VOCSN Multi-Function Ventilators due to a component failure that may cause the device to unexpectedly shut down or lose blower function while in use. When this occurs, the ventilator may be unable to provide necessary ventilation therapy to patients.
The recall affects approximately 1,934 ventilators across multiple models and versions. The affected devices have been distributed in the United States, Hong Kong, and Japan. The manufacturer has identified specific serial numbers associated with the failure.
The recalled product
- 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…
- Manufacturer
- Ventec Life Systems, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 114304
- 113728
- 113729
- 113697
- 114296
- 113587
- 113684
- 113706
- 113003
- 112957
- 112961
- 112962
- 112965
- 112972
- 112974
- 112994
- 112995
- 112999
- 113006
- 113008
Distribution
Distributed nationwide across the United States.
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