FDA Medical Device Recalls (openFDA)
Ventec Life Systems, Inc.: 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
- Recall number
- Z-1196-2025
- Recalling firm
- Ventec Life Systems, Inc.
- 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
- Status
- Open, Classified
- Initiated
- 2025-02-03
- Posted
- 2025-02-26
- Terminated
- not on file
- 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.
- Root 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
- 30
- Distribution
- US distribution in CA, NY, and MO.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K162877"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 3013095415
- Firm city
- Bothell
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28