Breas Medical AB recalls Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care

Recall date

November 7, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2094-2015

FDA classification

Class II

Brand / firm

Breas Medical AB

Sold / distributed

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…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care