FDA Medical Device Recalls (openFDA)
Breas Medical AB: Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care
- Recall number
- Z-2094-2015
- Recalling firm
- Breas Medical AB
- Product
- Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care
- Status
- Terminated
- Initiated
- 2014-11-07
- Posted
- 2015-07-16
- Terminated
- 2016-04-07
- Reason
- Unintended treatment termination could result from a keypad malfunction in some situations. The device erroneously interprets this as a Stop Treatment Instruction. An alarm will not sound, or be registered. Accessories and monitoring equipment connected to the Vivo 50 will stop functioning as the device enters stand-by mode.
- Root cause
- Device Design
- Action
- Breas Medical sent Urgent Release: Field Safety Notice letters dated November 7, 2014 and Field Safety Notice dated November 21, 2014 to their customers. The letters identified the affected product, problem and the actions to be taken.
- Quantity
- 846 US
- Distribution
- Worldwide - United States Nationwide Distribution and the countries: Argentina, Belgium, Chile, Cyprus, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Malaysia, Netherlands, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Thailand, Turkey, UAE and United Kingdom.
- Lot, serial or model codes
- All Vivo 50 Ventilators (215000, 215016) with firmware version 2.04
- 510(k) numbers
- ["K123144"]
- PMA numbers
- not on file
- Product code
- NOU
- Firm FEI
- 3003244771
- Firm city
- Molnlycke
- Firm state
- not on file
- Firm country
- Sweden
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