Z-2094-2015Class II

Breas Vivo 50 Home Care Ventilator

Name: Z-2094-2015 Breas Vivo 50 Home Care Ventilator
Creator: Breas Medical AB
Published: 2014-11-07
License: https://open.fda.gov/license/

Breas Medical AB / initiated 2014-11-07 / Terminated / root cause: design

FDA source

Breas Medical AB began a recall of Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care on 2014-11-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2094-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-07
Posted: 2015-07-16
Terminated: 2016-04-07
Recalling firm: Breas Medical AB
Product: Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care
Product code: NOU Continuous, Ventilator, Home Use
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.
Root cause tag: design
FDA 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 in commerce: 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, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Thailand, Turkey, UAE and United Kingdom.
Product codes and lots: All Vivo 50 Ventilators (215000, 215016) with firmware version 2.04

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2094-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2094-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-22	2015-07-16

Product code NOU

K123144Class IIVivo 50Ge Healthcare, Breas Medical AB / cleared 2013-06-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)