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U.S. Department of Health and Human Services

Class 1 Device Recall Vivo 45 LS

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 Class 1 Device Recall Vivo 45 LSsee related information
Date Initiated by FirmJuly 25, 2024
Date PostedSeptember 03, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2690-2024
Recall Event ID 95042
510(K)NumberK193586 
Product Classification Continuous, ventilator, home use - Product Code NOU
ProductVivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Number: 230000 (230016, 230216)
Code Information Model No 230000; UDI-DI 07321822300004; Lot Code: all lots up to 240530.
Recalling Firm/
Manufacturer
Breas Medical, Inc.
16 Esquire Rd
North Billerica MA 01862-2527
For Additional Information Contact
617-286-5509
Manufacturer Reason
for Recall
There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific conditions.
FDA Determined
Cause 2
Under Investigation by firm
ActionOn August 5, 2024, URGENT MEDICAL DEVICE CORRECTION letters were sent to consignees. Actions to be taken by Customer / User: 1. Since the elevated levels of formaldehyde were observed with the Vivo 45 LS operated at higher room temperatures, 40C (104F), as a matter of precaution, Breas Medical is lowering the maximum room air temperature for operation of the device from 40C (104F) to 30C (86F). 2. The following additional measure applies to new Vivo 45 LS devices distributed on or before July 24, 2024, that have not been in use for at least 14 days: Pre-run the device for at least 14 days in an ambient room temperature of at least 20C (68F). The pre-run can be performed in any ventilation treatment mode (for example: CPAP at 4 cmH2O). Make sure that the device s air outlet is not blocked, so that the air flows out from the device. Devices being pre-run should be in a dedicated, well-ventilated room. Personnel working with the devices should be in the room only intermittently, for time needed to connect and setup or disconnect devices. 3. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. 4. Retain this document as an addendum to the Instructions for Use and for your records. Please keep a copy of this document available with the Instructions for Use. 5. Complete and return the attached acknowledgement form to vivotechnicalsupport@breas.com and inga.dolezar@breas.com (You only need to send one acknowledgement form.) Contact Information: If you have any questions or concerns regarding this notification, please contact Breas Medical Inc. service or your local Service Representative. Breas Medical Inc. service can be reached at 855-436-8724 ext. 110 between 8.00am and 5.00pm ET Mondays through Fridays, or by e-mail vivotechnicalsupport@breas.com.
Quantity in Commerce8298
DistributionUS Nationwide.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NOU
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