Device recall
V+Pro Model Number: PRT-01185-000, Package PN:PRT-01198-000; Model Number: PRT-01185-001, Package PN: N/A; Model Number: PRT-01185-002, Package PN:N/A. used for ventilatory support.
- Recall number
- Z-0129-2027
- Event id
- 99835
- Status
- Ongoing
- FDA classification
- Class I
- Recalling firm
- Ventec Life Systems, Inc.
- Report date
- Oct 28, 2026
- Posted
- Oct 20, 2026
- Initiated
- Sep 17, 2026
- Center classification date
- Oct 20, 2026
- Product code
- CBK
- Device type
- Ventilator, Continuous, Facility Use
- Reason
- Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
- Root cause
- Under Investigation by firm
- Quantity
- 39,568 units
- Code info
- All Serial Numbers: PRT-01185-000 -UDI: 00855573007877; PRT-01185-001 - UDI: 00850018761161; PRT-01185-002 - UDI: 00850018761154
- Distribution
- Distribution US nationwide including Puerto Rico.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K162877
- Location
- Bothell, WA, United States