Z-1196-2025Class I

VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro...

Name: Z-1196-2025 VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro...
Creator: Ventec Life Systems, Inc.
Published: 2025-02-03
License: https://open.fda.gov/license/

Ventec Life Systems, Inc. / initiated 2025-02-03 / Open, Classified

FDA source

Ventec Life Systems, Inc. began a recall of 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 on 2025-02-03. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1196-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-02-03
Posted: 2025-02-26
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
Product code: CBK Ventilator, Continuous, Facility Use
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 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 [email protected] 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1196-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1196-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-03-05	2025-02-26

Product code CBK

K162877Class IIVOCSN Unified Respiratory SystemVentec Life Systems, Inc. / cleared 2017-04-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)