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Breas Medical AB recalls Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care
Recalled July 22, 2015 · FDA recall Z-2094-2015 · 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. · FDA Class II
Units
846 US
Sold at
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.
Description
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.
Product
Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care
Manufacturer(s)
Breas Medical AB
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →