Ventec Life Systems, Inc. medical device recall: VOCSN Multi-Function Ventilators: VOCSN+Pro
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 96136
- Recall initiated
- Feb 3, 2025
- Classified by FDA
- Feb 26, 2025
- Posted in Enforcement Report
- Mar 5, 2025
- Recalling firm
- Ventec Life Systems, Inc.
- Firm location
- Bothell, WA, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an active circuit could result in inaccurate tidal volume monitor, not triggering on patient efforts, less inspiratory volume, less inspiratory pressure, and less PEEP delivered.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Feb 3, 2025. FDA classified it 23 days later, on Feb 26, 2025. Distribution reported by FDA: US distribution in CA, NY, and MO. Ventec Life Systems, Inc. has 7 recalls in our records.
Recalled products (1)
Z-1196-2025 Class I Ongoing
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
Codes / lots: 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, 5040762, 5041060, 5041078, 5041534, 5042558, 117344, 118464, 118509, 5039387; PRT-01185-002/00850018761154/5037655
Quantity: 30
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 96136
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.