FDA Medical Device Recalls (openFDA)
Breas Medical, Inc.: 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)
- Recall number
- Z-2690-2024
- Recalling firm
- Breas Medical, Inc.
- 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)
- Status
- Open, Classified
- Initiated
- 2024-07-25
- Posted
- 2024-09-03
- Terminated
- not on file
- Reason
- 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.
- 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 vivotechnicalsupport@breas.com and inga.dolezar@breas.com (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 vivotechnicalsupport@breas.com.
- Quantity
- 8298
- Distribution
- US Nationwide.
- Lot, serial or model codes
- Model No 230000; UDI-DI 07321822300004; Lot Code: all lots up to 240530.
- 510(k) numbers
- ["K193586"]
- PMA numbers
- not on file
- Product code
- NOU
- Firm FEI
- 3010817335
- Firm city
- North Billerica
- Firm state
- MA
- 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