Recall Z-0126-2027— Ventec Life Systems, Inc.

Name: FDA recall Z-0126-2027
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. It names one FDA 510(k) clearance: K162877. Product: VOCSN Model Number: PRT-01100-000, Package PN:PRT-01126-000. 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

510(k) clearances named in this recall

1 on FDA's record

K162877 — VOCSN Unified Respiratory SystemVentec Life Systems, Inc.·cleared 2017-04-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

VOCSN Model Number: PRT-01100-000, Package PN:PRT-01126-000. 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.