Recall Z-2094-2015 ยท NOU Continuous, Ventilator, Home Use
Breas Medical AB
Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care
| Date | Jul 16, 2015 (initiated Nov 7, 2014) |
| Status | Terminated |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123144 | VIVO 50 Ge Healthcare, Breas Medical AB, Jun 18, 2013 |