Breas Medical AB: Medical Device Recall in 2015 - (Recall #: Z-2094-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care

Product Classification:

Class II

Date Initiated: November 7, 2014

Date Posted: July 22, 2015

Recall Number: Z-2094-2015

Event ID: 69760

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.

Status: Terminated

Product Quantity: 846 US

Code Information:

All Vivo 50 Ventilators (215000, 215016) with firmware version 2.04

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.

Voluntary or Mandated:

Voluntary: Firm initiated