Recall Z-0133-2027— Ventec Life Systems, Inc.

Name: FDA recall Z-0133-2027
Creator: U.S. Food and Drug Administration
Published: 2026-09-17

Class I · Ongoing

Class I FDA medical device recall by Ventec Life Systems, Inc., initiated 2026-09-17. FDA's recall record names no specific 510(k) clearance for this event. Product: V*Home, Model Number: PRT-01444-000, Package PN:PRT-01445-000. used for ventilatory support.. Reason: Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy..

Recalling firm: Ventec Life Systems, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2026-09-17
Firm location: Bothell, WA, United States

Product description

V*Home, Model Number: PRT-01444-000, Package PN:PRT-01445-000. used for ventilatory support.

Reason for recall

Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.

Data sourced from openFDA. This site is unofficial and independent of the FDA.