Recall Z-1196-2025— Ventec Life Systems, Inc.

Name: FDA recall Z-1196-2025
Creator: U.S. Food and Drug Administration
Published: 2025-02-03

Class I · Ongoing

Class I FDA medical device recall by Ventec Life Systems, Inc., initiated 2025-02-03. It names one FDA 510(k) clearance: K162877. Product: VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF: PRT-01185-000, PRT-01185-002. Reason: Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an active circuit could result in inaccurate tidal volume monitor, not triggering on patient efforts, less inspiratory volume, less inspiratory pressure, and less PEEP delivered..

Recalling firm: Ventec Life Systems, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2025-02-03
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 Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF: PRT-01185-000, PRT-01185-002

Reason for recall

Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an active circuit could result in inaccurate tidal volume monitor, not triggering on patient efforts, less inspiratory volume, less inspiratory pressure, and less PEEP delivered.

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