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Terminated

Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care

FDA Recall Z-2094-2015 · Posted 2015-07-16

Recalling FirmBreas Medical AB
Recall StatusTerminated
Product CodeNOU
Date Initiated2014-11-07
Date Terminated2016-04-07
Product Quantity846 US

Reason for Recall

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123144VIVO 50Ge Healthcare, Breas Medical AB · 2013-06-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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