Class 1 Device Recall VOCSN MultiFunction Ventilators: VOCSNPro and VPro

• Date Initiated by Firm: February 03, 2025
• Date Posted: February 26, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1196-2025
• Recall Event ID: 96136
• 510(K)Number: K162877
• Product Classification: Ventilator, continuous, facility use - Product Code CBK
• 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
• Code Information: REF/UDI-DI/Serial Numbers: PRT-00490-001/00855573007792/123627, 121892, 119639; PRT-01185-000/00855573007877/5038421, 116700, 117933, 5038112, 5038619, 5038717, 5038953, 5039086, 5039091, 5039361, 5039499, 5039503, 5039541, 5039636, 5039938, 5040019, 5040640, 5040762, 5041060, 5041078, 5041534, 5042558, 117344, 118464, 118509, 5039387; PRT-01185-002/00850018761154/5037655
• FEI Number: 3013095415
• Recalling Firm/ Manufacturer: Ventec Life Systems, Inc.; 22002 26th Ave Se; Bothell WA 98021-4903
• For Additional Information Contact: 425-686-1722
• Manufacturer 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.
• FDA Determined Cause: Component change control
• Action: On 02/03/2025, recall notices were sent to Durable Medical Equipment Distributors asking them to do the following: Clinical Action: Follow internal procedures to transfer the patient to an alternative source of ventilation, if available. If no other ventilation method is available, you may continue to use the affected product adhering to the guidelines below, while you await device correction by firm Service personnel: 1. Use only when the patient is actively monitored to ensure timely response to a potential malfunction. 2. Operate the ventilator as defined in the Instructions for Use and promptly respond to all alarms activated by the ventilator. 3. Use external monitors (e.g. SpO2) and set the alarm thresholds appropriately for the patient. 4. Connect the ventilator to an external monitoring system, wherever possible. Also, Durable Medical Equipment Distributors are asked to acknowledge they forwarded the recall notice, and that they contacted the users to which the devices were provided, advised them of the recall and action instructions within accompanying Recall Notification Letter including how to have the devices repaired. Complete and return the acknowledgement form via email to Ventec-Recall@reacthealth.com For any questions contact the firm at at 844-MYVOCSN (844-698-6276), Monday through Friday between 8:00 a.m. - 5:00 p.m. PDT.
• Quantity in Commerce: 30
• Distribution: US distribution in CA, NY, and MO.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = CBK