Device recall
VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilatory support.
- Recall number
- Z-0127-2027
- 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
- 100 units
- Code info
- All Serial Numbers: UDI: 00850018761130
- Distribution
- Distribution US nationwide including Puerto Rico.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K162877
- Location
- Bothell, WA, United States