FDA-Device2015-07-22Class II
Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care
Breas Medical AB
Hazard
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.
Sold states
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.
Affected count
846 US
Manufactured in
Foretagsvagen 1, N/A, Molnlycke, N/A, Sweden
Products
Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2094-2015Don't want to check this manually?
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