Z-2690-2024Class I

Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory...

Name: Z-2690-2024 Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory...
Creator: Breas Medical, Inc.
Published: 2024-07-25
License: https://open.fda.gov/license/

Breas Medical AB / initiated 2024-07-25 / Open, Classified

FDA source

Breas Medical, Inc. began a recall of Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or... on 2024-07-25. FDA classified it as Class I and gives the reason as "There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific conditions". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2690-2024
Classification: Class I
Status: Open, Classified
Initiated: 2024-07-25
Posted: 2024-09-03
Recalling firm: Breas Medical AB
Product: Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Number: 230000 (230016, 230216)
Product code: NOU Continuous, Ventilator, Home Use
Reason for recall: There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific conditions.
FDA root cause: Under Investigation by firm
Action: On August 5, 2024, URGENT MEDICAL DEVICE CORRECTION letters were sent to consignees. Actions to be taken by Customer / User: 1. Since the elevated levels of formaldehyde were observed with the Vivo 45 LS operated at higher room temperatures, 40C (104F), as a matter of precaution, Breas Medical is lowering the maximum room air temperature for operation of the device from 40C (104F) to 30C (86F). 2. The following additional measure applies to new Vivo 45 LS devices distributed on or before July 24, 2024, that have not been in use for at least 14 days: Pre-run the device for at least 14 days in an ambient room temperature of at least 20C (68F). The pre-run can be performed in any ventilation treatment mode (for example: CPAP at 4 cmH2O). Make sure that the device s air outlet is not blocked, so that the air flows out from the device. Devices being pre-run should be in a dedicated, well-ventilated room. Personnel working with the devices should be in the room only intermittently, for time needed to connect and setup or disconnect devices. 3. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. 4. Retain this document as an addendum to the Instructions for Use and for your records. Please keep a copy of this document available with the Instructions for Use. 5. Complete and return the attached acknowledgement form to [email protected] and [email protected] (You only need to send one acknowledgement form.) Contact Information: If you have any questions or concerns regarding this notification, please contact Breas Medical Inc. service or your local Service Representative. Breas Medical Inc. service can be reached at 855-436-8724 ext. 110 between 8.00am and 5.00pm ET Mondays through Fridays, or by e-mail [email protected].
Quantity in commerce: 8298
Distribution: US Nationwide.
Product codes and lots: Model No 230000; UDI-DI 07321822300004; Lot Code: all lots up to 240530.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2690-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2690-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-11	2024-09-03

Product code NOU

K193586Class IIVivo 45 LSBreas Medical AB / cleared 2021-01-27

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)