FDA Medical Device Recalls (openFDA)
Breas Medical, Inc.: Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Model Number: 230000 If the recalled product is a software, include version number: firmware versions 5.0.5 or earlier
- Recall number
- Z-1382-2022
- Recalling firm
- Breas Medical, Inc.
- Product
- Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Model Number: 230000 If the recalled product is a software, include version number: firmware versions 5.0.5 or earlier
- Status
- Open, Classified
- Initiated
- 2022-06-02
- Posted
- not on file
- Terminated
- not on file
- Reason
- A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AND the instructions to monitor a ventilator dependent patient are NOT followed, the health consequences could potentially be Permanent impairment or life threatening if medical intervention is not obtained
- Root cause
- Device Design
- Action
- Breas Medical contacted consignees initially by phone beginning 6/2/22 followed by email Urgent Medical Device Recall Firmware Upgrade letter Letter states reason for recall, health risk and action to take: Customers are required to identify all affected Vivo 45 LS ventilators and apply the firmware upgrade to firmware version 5.0.7 (or later) within 12 months. Breas has implemented a firmware correction to resolve the problem and can confirm that Vivo 45LS with firmware versions 5.0.7 or higher, distributed after March 29th, 2022 are not affected by this issue. Confirmation of receipt We kindly ask you to acknowledge receipt of this Recall Notice together with your choice to remedy the issue using attached reply form Vivo 45 LS Firmware Upgrade Customer Reply Form. Helpline +1 (855) 436-8724
- Quantity
- 1,113 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Unique Device Identifier (UDI): UDI 07321822300004. Serial number ranges in scope are: D******, K******, M01**** to M040124, where asterisk (*) denotes a digit from 0 to 9.
- 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