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U.S. Department of Health and Human Services

Class 2 Device Recall Breas Vivo 50 Home Care Ventilator

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  Class 2 Device Recall Breas Vivo 50 Home Care Ventilator see related information
Date Initiated by Firm November 07, 2014
Date Posted July 16, 2015
Recall Status1 Terminated 3 on April 07, 2016
Recall Number Z-2094-2015
Recall Event ID 69760
510(K)Number K123144  
Product Classification Continuous, ventilator, home use - Product Code NOU
Product Breas Vivo 50 Home Care Ventilator

Product Usage:
Respiratory Care
Code Information All Vivo 50 Ventilators (215000, 215016) with firmware version 2.04
Recalling Firm/
Manufacturer		 Breas Medical AB
Foretagsvagen 1
Molnlycke Sweden
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NOU and Original Applicant = GE HEALTHCARE, BREAS MEDICAL AB
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