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U.S. Department of Health and Human Services

Class 2 Device Recall Breas Medical Inc.

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  Class 2 Device Recall Breas Medical Inc. see related information
Date Initiated by Firm June 02, 2022
Create Date July 13, 2022
Recall Status1 Open3, Classified
Recall Number Z-1382-2022
Recall Event ID 90433
510(K)Number K193586  
Product Classification Continuous, ventilator, home use - Product Code NOU
Product Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation

Model Number: 230000

¿ If the recalled product is a software, include version number: firmware versions 5.0.5 or earlier
Code Information Unique Device Identifier (UDI): UDI 07321822300004.  Serial number ranges in scope are: D******, K******, M01**** to M040124, where asterisk (*) denotes a digit from 0 to 9.
Recalling Firm/
Manufacturer		 Breas Medical, Inc.
16 Esquire Rd
North Billerica MA 01862-2527
For Additional Information Contact hris Southerland
617-286-5509
Manufacturer Reason
for Recall		 A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AND the instructions to monitor a ventilator dependent patient are NOT followed, the health consequences could potentially be Permanent impairment or life threatening if medical intervention is not obtained
FDA Determined
Cause 2		 Device Design
Action Breas Medical contacted consignees initially by phone beginning 6/2/22 followed by email Urgent Medical Device Recall Firmware Upgrade letter Letter states reason for recall, health risk and action to take: Customers are required to identify all affected Vivo 45 LS ventilators and apply the firmware upgrade to firmware version 5.0.7 (or later) within 12 months. Breas has implemented a firmware correction to resolve the problem and can confirm that Vivo 45LS with firmware versions 5.0.7 or higher, distributed after March 29th, 2022 are not affected by this issue. Confirmation of receipt We kindly ask you to acknowledge receipt of this Recall Notice together with your choice to remedy the issue using attached reply form Vivo 45 LS Firmware Upgrade Customer Reply Form. Helpline +1 (855) 436-8724
Quantity in Commerce 1,113 units
Distribution Nationwide
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = NOU and Original Applicant = Breas Medical AB
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