Z-2094-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 22, 2015
- Initiation Date
- November 7, 2014
- Termination Date
- April 7, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 846 US
Product Description
Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care
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.
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.
Code Information
All Vivo 50 Ventilators (215000, 215016) with firmware version 2.04