Ventec VOCSN Ventilators Recalled Due to Incorrect Service Parts
Ventec Life Systems recalled VOCSN Multi-Function Ventilators (30 units in CA, NY, MO) due to incorrect parts used during service. Defects may cause unexpected shutdown or impaired respiratory monitoring and support.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall without reported deaths or illnesses, which establishes a Severe (4) rating per regulatory guidance. The defect directly affects critical ventilator functions with potential for unexpected device shutdown and impaired respiratory support delivery.
Plain-English summary
Ventec Life Systems, Inc. has recalled VOCSN Multi-Function Ventilators, specifically the VOCSN+Pro and V+Pro models, distributed in the United States. The devices were serviced using incorrect parts during maintenance.
The incorrect parts create a risk of serious malfunction. Specifically, the ventilators may experience unexpected shutdown. The devices may also display inaccurate tidal volume monitoring, fail to trigger on patient breathing efforts, and deliver less inspiratory volume, less inspiratory pressure, and less PEEP (positive end-expiratory pressure) than clinically intended.
A total of 30 units have been identified and recalled. Distribution was limited to three states: California, New York, and Missouri. The affected units are identified by specific serial numbers and reference numbers provided by the manufacturer.
Healthcare providers and facilities with these ventilators should verify equipment serial numbers against the recall notice and contact Ventec Life Systems immediately to address the service defect.
The recalled product
- Product
- VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF: PRT-01185-000, PRT-01185-002
- Manufacturer
- Ventec Life Systems, Inc.
- Hazard
- unexpected-shutdown
- inaccurate-monitoring
- respiratory-insufficiency
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)
- REF/UDI-DI/Serial Numbers: PRT-00490-001/00855573007792/123627
- 121892
- 119639
- PRT-01185-000/00855573007877/5038421
- 116700
- 117933
- 5038112
- 5038619
- 5038717
- 5038953
- 5039086
- 5039091
- 5039361
- 5039499
- 5039503
- 5039541
- 5039636
- 5039938
- 5040019
- 5040640
Distribution
Distributed in 3 states:
- CA
- MO
- NY
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