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U.S. Department of Health and Human Services

Class 1 Device Recall bellavista

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  Class 1 Device Recall bellavista see related information
Date Initiated by Firm December 20, 2021
Create Date February 16, 2022
Recall Status1 Completed
Recall Number Z-0622-2022
Recall Event ID 89366
510(K)Number K183364  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130.

The bellavista 1000/1000e ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients, and optionally, infant and neonatal patients.
Code Information Hardware generation G6, software version V6.0.1600.0 or higher installed, all serial numbers. UDI 07640149381115 (bellavista 1000 ventilator) and 07640149388879 (bellavista 1000e ventilator).
Recalling Firm/
Manufacturer
Vyaire Medical
26125 N Riverwoods Blvd
Mettawa IL 60045-3420
For Additional Information Contact Dr. Michael Pedro
339-293-9211
Manufacturer Reason
for Recall
Potential cessation in ventilation can occur under specific conditions.
FDA Determined
Cause 2
Software change control
Action Foreign consignees were notified of the correction via email notification beginning 12/20/2021 Foreign consignees were notified of the correction via email notification beginning 12/20/2021 containing a Field Safety Notice, an Appendix to the Field Safety Notice which lists the affected units, an FSCA Distributor Response Form and an FSCA End User Response form, all in English, with the notation that localized versions were currently in translation and will be forwarded as soon as available, if applicable. The email provided information on the affected model numbers and actions to be taken by the distributor. These actions included notifying all affected end users by providing them with the FSCA package containing the notice and the list of affected units, notify the appropriate regulatory authorities as applicable, return the completed and signed FSCA Distributor Response form, and letting them know that if any user facilities have distributed affected products to other persons or facilities, promptly forward a copy of the Field Safety Notice and the list of affected units. The email informs them that imtmedical ag will inform them of the availability of the software patch in a separate communication for installation. The recalling firm, Vyaire Medical, issued two different notifications titled "URGENT: MEDICAL DEVICE CORRECTION" to distributors and end users on 12/23/2021 via electronic communication. Physical copies of the notification will be issued to each consignee via UPS Next Day Air delivery. The Distributor letter informed the distributor of the issue and provided a problem description, problem root cause, and said that in order to prevent adverse health consequences associated with this failure mode during use of the bellavista 1000 and bellavista 1000e ventilators, hardware generation G6, end users are encouraged to follow the User Manual and take the immediate mitigation actions listed in the End-User Notification package. The actions to be tak
Quantity in Commerce 4189 units
Distribution Worldwide distribution - US Nationwide distribution in the states of AL, CA, CO, CT, DC, FL, GA, ID, IL, IN, LA, MA, MD, MI, MO, MS, NC, NJ, NY, OH, OK, PA, SD, TX, VA, WA, WI and WV, including Puerto Rico and the countries of Argentina, Australia, Austria, Bahrain, Belgium, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Dominican Republic, Egypt, El Salvador, France, Germany, Guatemala, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lithuania, Malaysia, Mexico, Namibia, Netherlands, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, South Africa, South Korea, Spain, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam, and Zimbabwe.
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.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = Imtmedical AG
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