FDA recall, , High risk
Ventec Life Systems VOCSN, V+Pro, VC and V*Home Ventilators
The ventilator's internal flow transducer cable connector may disconnect from the internal board.
Summary by Recall Canary from the FDA notice
What happened
Ventec Life Systems, Inc. recalled the ventilator's internal flow transducer cable connector may disconnect from the internal board, potentially resulting in system reboot and interruption of ventilation therapy. The recall began September 17, 2026, and was added to the FDA's Enforcement Report on October 20, 2026. Distribution was US nationwide including Puerto Rico.
The affected products include V*Home, Vocsn, Vocsn (Japan), Vocsn+Pro (Japan), VCSN+Pro, VC, Vocsn+Pro, VC+Pro, V+ Pro Emergency, V+Pro, VC+Pro (Japan), and VC (Japan).
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your package affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
VOCSN+Pro
- Model
- PRT-00490-001
VOCSN+Pro (Japan)
- Model
- PRT-00490-100
VC+Pro
- Model
- PRT-00900-001
VC+Pro (Japan)
- Model
- PRT-00900-100
PRT-01100-000, Package PN:PRT-01126-000. used for ventilatory support.
- Model
- VOCSN
VOCSN (Japan)
- Model
- PRT-01100-100
VCSN+Pro
- Model
- PRT-01184-000
- Lot code
- All Serial Numbers: UDI: 00855573007860
V+Pro
- Model
- PRT-01185-000
PRT-01185-001
- Model
- PRT-01185-001
PRT-01185-002
- Model
- PRT-01185-002
- Lot code
- All Serial Numbers: PRT-01185-000 -UDI: 00855573007877, PRT-01185-001 - UDI: 00850018761161, PRT-01185-002 - UDI: 00850018761154
PRT-01098-000, Package PN:PRT-01125-000. used for ventilatory support.
- Model
- VC
VC(Japan)
- Model
- PRT-01098-100
V+ Pro Emergency
- Model
- PRT-01201-000
- Lot code
- All Serial Numbers: UDI: 00855573007945
V*Home
- Model
- PRT-01444-000
V*Home, Model Number: PRT-01444-000, Package PN:PRT-01445-000. used for ventilatory support.
- Lot code
- All Serial Numbers: UDI: 00855573007822
VOCSN Model Number: PRT-01100-000, Package PN:PRT-01126-000. used for ventilatory support.
- Lot code
- All Serial Numbers: UDI: 00855573007747
VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilatory support.
- Lot code
- All Serial Numbers: UDI: 00850018761130
VC Model Number: PRT-01098-000, Package PN:PRT-01125-000. used for ventilatory support.
- Lot code
- All Serial Numbers: UDI: 00855573007730
VC+Pro (Japan) Model Number: PRT-00900-100, Package PN:PRT-00973-100. used for ventilatory support.
- Lot code
- All Serial Numbers: UDI: 00855573007211
From the FDA notice
Model Number:PRT-00490-001, Package PN:PRT-00853-000. used for ventilatory support.
Recall details
- Company began the recall
- Sold in
Distribution US nationwide including Puerto Rico.
- Company
- Ventec Life Systems, Inc.
- Hazard
- Device defect
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 99835
- Recall numbers
- Z-0122-2027 to Z-0133-2027
All recalls from Ventec Life Systems, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
